Pfizer
Immune system & inflammation symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | lymph node pain, lymph node swelling |
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache...
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No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
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| 40 | 2020-12-31 | lymph node swelling |
Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on ...
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Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on right side after one week of injection. Bilateral swelling of lymph nodes by day nine.
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| 40 | 2021-01-02 | lymph node swelling, lymph node pain |
Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Ini...
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Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days
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| 40 | 2021-01-03 | axillary mass |
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; ...
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I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
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| 40 | 2021-01-03 | peripheral swelling |
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ...
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Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
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| 40 | 2021-01-04 | lymph node swelling |
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s...
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One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
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| 40 | 2021-01-04 | swelling face, swelling, swelling |
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4...
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Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-05 | swelling |
Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion...
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Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.
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| 40 | 2021-01-06 | swelling | Angioedema & UrticariaPruritus |
| 40 | 2021-01-06 | peripheral swelling |
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i...
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Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
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| 40 | 2021-01-06 | swelling face | EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm |
| 40 | 2021-01-06 | swelling |
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j...
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Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
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| 40 | 2021-01-06 | swelling |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-07 | lymph node swelling | The next day had headache and right axillary swelling and tender right axillary lymph nodes. |
| 40 | 2021-01-07 | swelling face |
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re...
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Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
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| 40 | 2021-01-07 | swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue a...
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Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.
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| 40 | 2021-01-08 | lymph node pain, lymph node swelling | Swollen and painful left infraclavicular lymph node 2 days after 2nd COVID vaccine |
| 40 | 2021-01-08 | lymph node swelling | Swollen left tonsillar lymph node and left sore throat |
| 40 | 2021-01-09 | anaphylactic reaction |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | lymph node swelling |
Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen co...
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Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.
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| 40 | 2021-01-09 | swelling face |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-10 | lymph node swelling | I had large red and hot welt. I had lip node enlargement. It lasted for a week. |
| 40 | 2021-01-10 | swelling face |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | swelling |
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ...
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Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
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| 40 | 2021-01-10 | swelling |
The day after the injection she noticed swelling in her right axilla that is painful but no redness....
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The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.
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| 40 | 2021-01-11 | lymph node swelling |
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours...
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swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
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| 40 | 2021-01-11 | lymph node swelling |
Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable ph...
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Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable physician. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included Known allergies with Penicillin. The patient was not pregnant. The patient was not diagnosed with COVID-19prior to vaccination. There were no concomitant medications. On 21Dec2020, the patient experienced Lymphadenopathy supraclavicular nodes, left side starting day 3 post vaccine and persistent to current with outcome of recovering. There was no treatment reported for the event. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination.
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| 40 | 2021-01-11 | swelling |
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021...
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lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
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| 40 | 2021-01-11 | swelling |
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec...
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Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
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| 40 | 2021-01-12 | lymph node pain, lymph node swelling |
Severe lymphadenopathy. Lymph nodes on the left side across upper chest, clavicle, and left arm, an...
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Severe lymphadenopathy. Lymph nodes on the left side across upper chest, clavicle, and left arm, and left arm pit were swollen and painful.
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| 40 | 2021-01-12 | lymph node swelling | Left axillary lymphadenopathy, headache, muscle ache, fatigue. |
| 40 | 2021-01-12 | swollen extremities | Starting the day after the injection she began experiencing pain and swelling in her armpit. |
| 40 | 2021-01-12 | peripheral swelling, lymph node swelling |
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va...
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?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
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| 40 | 2021-01-13 | anaphylactic reaction |
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio...
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Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
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| 40 | 2021-01-13 | lymph node pain, lymph node swelling | Swollen lymph nodes in left armpit and tender to touch. |
| 40 | 2021-01-13 | lymph node swelling, lymph node pain |
LYMPH NODES SWOLLEN UNDER ARM UNDER ARM SORE AND TENDER TO TOUCH NO TREATMENT, 1 WEEK LATER CONTI...
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LYMPH NODES SWOLLEN UNDER ARM UNDER ARM SORE AND TENDER TO TOUCH NO TREATMENT, 1 WEEK LATER CONTINUES TO BE SORE BUT SWELLING AND PAIN HAS DECREASED DAY BY DAY
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| 40 | 2021-01-13 | lymph node swelling |
Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight naus...
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Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea
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| 40 | 2021-01-14 | lymph node swelling, lymph node pain |
Swollen and painful lymph nodes under arms; Swollen and painful lymph nodes under arms; This is a sp...
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Swollen and painful lymph nodes under arms; Swollen and painful lymph nodes under arms; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) via intramuscular route in the left arm, on 07Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Relevant medical history included anxiety, depression, hypothyroid, and hypertension. The patient has no known allergies. Concomitant medications included levothyroxine, escitalopram, paracetamol (TYLENOL), ibuprofen, and marijuana. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) intramuscular route in the left arm, on 18Dec2020 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced swollen and painful lymph nodes under arms. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 40 | 2021-01-14 | lymph node swelling |
Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reporte...
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Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 40-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: el0142) at the hospital, intramuscular in the left arm on 06Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included "COVID prior vaccination Yes" on an unspecified date. The patient was not pregnant at the time of reporting. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 with lot number: EK7530 at age 40 years, via intramuscular route in the left arm, on 16Dec2020 at 12:00 PM, Nasal Swab test result was positive on 28Dec2020. The patient experienced lymphadenopathy on 07Jan2021 at 19:00. The event was considered as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-15 | swollen extremities, lymph node swelling |
1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 h...
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1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 hours (8pm) I developed pain and swelling in my left armpit. I went to bed and woke up with the same swelling and pain. Checked in at Urgent Care 1/15/20 swelling started in glands in neck around mid day.
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| 40 | 2021-01-17 | peripheral swelling |
102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headach...
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102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.
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| 40 | 2021-01-18 | guillain-barre syndrome |
Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospi...
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Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospital. She was diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is stable.
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| 40 | 2021-01-18 | swollen extremities |
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATI...
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STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
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| 40 | 2021-01-18 | peripheral swelling |
severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had...
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severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had Flare a week after first vaccine; Had flare a week after first vaccine with mild foot swelling; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ej1685), via an unspecified route of administration on 17Dec2020 at 08:00 AM on Right arm at single dose for COVID-19 immunization in hospital. Medical history included possible asthma, left foot post traumatic arthritis with multiple surgeries including precious allograft, meralgia paresthetica left side otherwise healthy (History of mild arthritis foot and ankle surgery). Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had history of mild arthritis foot and ankle surgery, she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain in Dec2020, severe arm pain about 2 hours after vaccine with difficulty lifting arm for 24 hours after vaccine on 17Dec2020. Took mefenamic acid (ADVIL) for pain. Elevated feet for swelling. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event 'severe leg and foot pain/severe arm pain' included mefenamic acid (ADVIL), for event 'foot swelling' included Elevated feet; no treatment was received for the other events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 40 | 2021-01-19 | lymph node pain, lymph node swelling |
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi...
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Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-19 | lymph node pain |
Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physic...
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Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physician(patient). This 40-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EK4176), intramuscular at left arm on 09Jan2021 09:15 at single dose for covid-19 immunisation. Medical history included Eosinophilic Esophagitis, chronic constipation, allergy to tree nuts. Concomitant medication included macrogol 3350 (MIRALAX). Patient previously received first dose BNT162B2 (Lot number: EH9899) intramuscular at left arm on 19Dec2020 14:30 at single dose for covid-19 immunisation. The patient experienced Left-sided tender supraclavicular lymph node developed the morning after 2nd dose of COVID vaccine on 10Jan2021 06:30 with outcome of recovering. No treatment was received. There was no other vaccine in four weeks, no covid prior vaccination, covid tested post vaccination. Event was non-serious.
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| 40 | 2021-01-19 | lymph node swelling |
Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, ...
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Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.
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| 40 | 2021-01-19 | peripheral swelling, lymph node swelling |
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera...
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Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
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| 40 | 2021-01-19 | peripheral swelling | Fatigue, Sore Throat, Runny Nose, General Malaise, Body aches, Swollen Arm |
| 40 | 2021-01-19 | swelling | Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills |
| 40 | 2021-01-19 | swelling |
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both...
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Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
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| 40 | 2021-01-21 | lymph node swelling | Swollen lymph node in armpit |
| 40 | 2021-01-21 | lymph node swelling |
1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left ar...
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1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left armpit and Red circle around injection site
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| 40 | 2021-01-21 | peripheral swelling | Body ache headache stiff neck stomach pain nausea vomiting arm swelling |
| 40 | 2021-01-23 | lymph node swelling |
Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area...
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Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.
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| 40 | 2021-01-24 | lymph node swelling, swollen extremities | Lymph Nodes under armpit extremely swollen and painful. Unable to lift arm completely without pain |
| 40 | 2021-01-24 | lymph node swelling |
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injecte...
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Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
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| 40 | 2021-01-24 | peripheral swelling | Extreme fatigue body aches chills sore and swollen arm |
| 40 | 2021-01-24 | swelling | Rash and Swelling on left side with Headache and fatigue |
| 40 | 2021-01-25 | lymph node pain, lymph node swelling |
swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after th...
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swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful; Swollen lymph nodes around left clavicle and close to armpit and neck; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took oxycodone and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Dec2020 07:00 PM, the patient experienced swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful. The outcome of the events was recovering. No treatment was given to the patient for the events.
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| 40 | 2021-01-25 | peripheral swelling |
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte...
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On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
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| 40 | 2021-01-25 | swelling face | Itching to face and chest around 3 hours after administration. Facial swelling noted overnight. |
| 40 | 2021-01-25 | swelling |
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; T...
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Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 40 | 2021-01-25 | swelling | On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches |
| 40 | 2021-01-26 | anaphylactic reaction |
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP...
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After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
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| 40 | 2021-01-26 | lymph node pain, lymph node swelling |
Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This...
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Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EC3246), via an unspecified route of administration at left arm on 12Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (Lot number: EK5730) at left arm for covid-19 immunization. The patient experienced enlarged and painful lymph node in left armpit on 13Jan2021 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
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| 40 | 2021-01-26 | swelling | Swelling with redness and low grade fever (topped at 100.4 degrees) |
| 40 | 2021-01-27 | lymph node swelling |
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with...
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Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
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| 40 | 2021-01-27 | swelling |
On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right inde...
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On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.
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| 40 | 2021-01-28 | lymph node swelling |
My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I ha...
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My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.
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| 40 | 2021-01-28 | peripheral swelling | fever 38.7, vomiting x2, chills, body ache, headache, swelling of left arm for the next three days. |
| 40 | 2021-01-28 | swelling face, peripheral swelling |
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too...
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Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
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| 40 | 2021-01-28 | swelling | Delayed onset of mild pain, swelling, erythema, paroxysmal moderate to intense pruritus. |
| 40 | 2021-01-30 | lymph node swelling | mild headache and moderate swollen lymph nodes |
| 40 | 2021-01-31 | lymph node swelling |
left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; ...
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left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-01-31 | peripheral swelling | Pain, swelling and large bump in left arm. Pain down in left hand. |
| 40 | 2021-01-31 | swelling face |
Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours ...
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Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours later; symptoms lasted 1 day.
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| 40 | 2021-02-01 | guillain-barre syndrome |
Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the f...
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Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
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| 40 | 2021-02-01 | lymph node swelling, lymph node pain |
Right sided supraclavicular lymph node enlargement and pain; Right sided supraclavicular lymph node ...
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Right sided supraclavicular lymph node enlargement and pain; Right sided supraclavicular lymph node enlargement and pain; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EJI1686), intramuscular in right arm, on 29Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included celecoxib (CELEXA), vitamin d [vitamin d nos] (unknown manufacturer), post natal vitamin. No any other vaccine within 4 weeks prior to the COVID vaccine was administered. The patient previously took butorphanol tartrate (STADOL) and experienced drug hypersensitivity. The patient experienced right sided supraclavicular lymph node enlargement and pain on an unspecified date with outcome of recovering. No treatment was given. The patient has not been tested for COVID-19 since the vaccination.
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| 40 | 2021-02-01 | peripheral swelling | Administration error. Vaccine given in the wrong route. Arm swelled up. |
| 40 | 2021-02-01 | peripheral swelling |
bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to l...
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bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to left thigh, Benadryl 50 mg PO, reduced hand swelling, T97.8 F BP 151/91 SpO2 99% P78. 911 was called, staff assessed pt, did not transport. Pt had friend transport to ER in private vehicle to seek higher level of care as a precaution.
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| 40 | 2021-02-01 | swelling face |
Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and f...
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Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and felt numb and swollen. A few minutes after that began, the back of my throat was scratchy. I took Benadryl 30 minutes after symptoms began and within 45 minutes all symptoms resolved. 7 hours following the Benadryl dosing, the symptoms returned. I took another dose of Benadryl. The symptoms resolved and did not return.
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| 40 | 2021-02-02 | swelling, peripheral swelling |
angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelli...
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angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.
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| 40 | 2021-02-02 | swelling face, peripheral swelling |
Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports sta...
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Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports starting Saturday positive swelling in face, hands and feet, reports improvement in swelling at this time. Positive full body aches, fever, significant fatigue and shortness of breath
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| 40 | 2021-02-03 | swelling face |
facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old fema...
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facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration in left arm om 11Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included seasonal allergies and urinary incontinence from an unknown date and unknown if ongoing. Concomitant medication included cetirizine, atenolol (NORTELOL) and oxybutynin. The patient was previously vaccinated with first dose of BNT162B2 (lot number: EH9899) via unspecified route in right arm ,on 22Dec2020 09:30 AM, for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced facial swelling on 11Jan2021 18:00 treated with diphenyhydramine (self administered). The outcome of the event was recovered on unspecified date.
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| 40 | 2021-02-03 | swelling face |
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne...
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Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
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| 40 | 2021-02-04 | lymph node swelling | Swollen axillary lymph node Swollen subclavical lymph nodes |
| 40 | 2021-02-04 | swelling face |
Shortly after the vaccination I was still having the abdominal distention so I called to see if I co...
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Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
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| 40 | 2021-02-08 | lymph node swelling |
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrh...
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on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
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| 40 | 2021-02-09 | lymph node swelling |
Swelling of lymph nodes in her armpit on the same side; This is a spontaneous report from a contacta...
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Swelling of lymph nodes in her armpit on the same side; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Jan2021 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not provided. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL1284) on 30Dec2020 for COVID-19 immunization.The patient reported swelling of lymph nodes in her armpit on the same side that she received BNT162B2 which she noticed yesterday around noon (as of 22Jan2020). She wanted to report, further asking if it was common and how long it would last. She noted that this event was not seen with the first dose and was unsure if this was normal or not. The patient took ibuprofen for treatment. The clinical outcome of swelling of lymph nodes in her armpit on the same side was reported as not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 40 | 2021-02-10 | lymph node swelling, lymph node pain |
Beginning 2/2/2021 I developed swollen, painful lymph nodes under my right arm and near the right si...
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Beginning 2/2/2021 I developed swollen, painful lymph nodes under my right arm and near the right side of my clavicle. I had visible swelling surrounding my right armpit. I felt fatigued and unwell, like I was sick.
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| 40 | 2021-02-10 | lymph node swelling |
Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain...
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Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
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| 40 | 2021-02-10 | peripheral swelling, swelling face |
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ...
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Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 40 | 2021-02-10 | swelling face |
Facial swelling; This is a spontaneous report from a contactable consumer (patient). A 40-year-old f...
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Facial swelling; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date was not reported), via an unspecified route of administration on 21Jan2021 at single for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. Patient reported that she had her first dose of the vaccine on Thursday (21Jan2021) and she experienced facial swelling on her right cheek. She got it that night and it still has not gone down. She went to the doctor yesterday and the dermatologist to ask them what she can do about it and they told her to report the side effects. The patient was advised by the doctor to try Zyrtec for a whole week and patient already took the first pill at the time of the report. The patient had not recovered from the event at the time of the report.
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| 40 | 2021-02-12 | swelling |
Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make...
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Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make it bearable. Still 3 weeks later not able to push or pull with arm, drive care, or lift with left arm-including taking off shirt, without pain. Able to pinpoint exact place injection was given and pain associated when pushing spot. Taking NSAIDS all day long to be able to move. Finally after 2 1/2 weeks made general physician appt because it is crazy how long and how bad my arm hurts. At that time still not able to lay on left arm or lift over head. Have been to chiropractor 3 time to help relieve shoulder/muscle pain.
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| 40 | 2021-02-13 | peripheral swelling, swelling face |
Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a ...
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Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a sunburn I was so red. I was very hot.
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| 40 | 2021-02-14 | peripheral swelling |
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w...
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red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
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| 40 | 2021-02-15 | lymph node swelling | Weakness and Pain in muscles and nerves in legs. Swollen lymph node in right arm pit. |
| 40 | 2021-02-16 | lymph node swelling |
Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in lef...
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Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable
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| 40 | 2021-02-16 | swelling face |
In monitoring area shortly after vaccination, patient reported to EMS observation staff she was expe...
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In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.
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| 40 | 2021-02-17 | lymph node swelling, swelling face, peripheral swelling |
had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which w...
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had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which went away when she got home. Since then, patient has had HA but noticed swelling to left shoulder on 1/9/21. neck: 3 cm x 3 cm left supraclavicular lymphadenopathy with tenderness to palpation give ibuprofen 600mg PO x1 and discharged with Ibuprofen
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| 40 | 2021-02-17 | swelling face |
WEDNESDAY: HA, BODY ACHE, FRIDAY: FACE SWOLLEN. HA. FRIDAY WENT TO ER. MONDAY: SEVERE HA, NAUSEA...
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WEDNESDAY: HA, BODY ACHE, FRIDAY: FACE SWOLLEN. HA. FRIDAY WENT TO ER. MONDAY: SEVERE HA, NAUSEA, SEVERE ACHES. WENT TO DR OFFICE.
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| 40 | 2021-02-19 | lymph node swelling | Swollen lymph node in neck, same side as injection site, lasted 2/14/21-2/18/21. |
| 40 | 2021-02-19 | peripheral swelling |
Woke up at 3am with aches all over my body in joints especially, and a headache. Experienced dry mou...
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Woke up at 3am with aches all over my body in joints especially, and a headache. Experienced dry mouth. Hands appeared swollen. Felt chills and a possible low grade fever, later one had a cold swear and pain continues at 4pm on the day after the dose.
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| 40 | 2021-02-21 | lymph node swelling |
Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to...
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Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.
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| 40 | 2021-02-21 | peripheral swelling |
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da...
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After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
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| 40 | 2021-02-22 | swelling face |
swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have litt...
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swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 40 | 2021-02-25 | swelling face |
I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic react...
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I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic reaction after eating walnuts on 1/30/21. I have never had reactions to nuts before. I had swelling, itching and rash on my face. I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts. I have also been having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane. Both hands feel stiff. Prior to the vaccinations, I have had no health conditions. I have an appointment w/ my PCP later in the month.
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| 40 | 2021-02-28 | lymph node swelling |
Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in lef...
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Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in left arm and neck region
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| 40 | 2021-02-28 | peripheral swelling |
Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and r...
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Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
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| 40 | 2021-02-28 | peripheral swelling |
patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local e...
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patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.
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| 40 | 2021-02-28 | swelling |
patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose ...
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patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.
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| 40 | 2021-03-02 | lymph node swelling |
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve...
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Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
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| 40 | 2021-03-03 | axillary mass | Sore, painful and swelling aroubd injection site. Painful lump in right armpit. |
| 40 | 2021-03-03 | lymph node pain, lymph node swelling |
I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and th...
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I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
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| 40 | 2021-03-03 | oral herpes |
After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside....
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After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside. Since 1st dose, have had 4 HSV1 cold sores come about. After 2nd dose experiencing severe heartburn. Also continue to have HSV1 cold sore outbreaks.
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| 40 | 2021-03-03 | swelling face |
Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: no...
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Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl
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| 40 | 2021-03-03 | swelling face |
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo...
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Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
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| 40 | 2021-03-04 | lymph node swelling, swelling |
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a...
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At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
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| 40 | 2021-03-04 | swelling face |
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi...
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After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
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| 40 | 2021-03-07 | swelling face |
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak...
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Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
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| 40 | 2021-03-08 | peripheral swelling |
Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after ...
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Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.
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| 40 | 2021-03-09 | lymph node swelling, lymph node pain |
The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and l...
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The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively. The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.
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| 40 | 2021-03-10 | lymph node swelling | Swollen arm pit lymph nodes swollen and painful |
| 40 | 2021-03-10 | lymph node swelling | Fever, swollen lymphnodes on right side of chest under armpit |
| 40 | 2021-03-11 | lymph node pain |
Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exha...
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Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm. The following day my body hurt, headache, mild nausea. Still have pain in lymph node under vaccinated arm and arm muscle twitch. Mild dehydration.
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| 40 | 2021-03-14 | lymph node swelling |
Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was...
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Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was noticeably swollen to the size of a small orange - symptom began to subside by morning of 3/15/21.
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| 40 | 2021-03-17 | peripheral swelling |
I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in ...
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I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.
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| 40 | 2021-03-18 | lymph node pain |
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa...
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Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
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| 40 | 2021-03-18 | lymph node swelling | large left supraclavicular lymphadenopathy |
| 40 | 2021-03-18 | peripheral swelling |
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t...
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I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
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| 40 | 2021-03-19 | swelling face, peripheral swelling |
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,...
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Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
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| 40 | 2021-03-20 | peripheral swelling | Arm swelled and and has tenderness week after covid Pfizer vaccine |
| 40 | 2021-03-22 | lymph node pain, lymph node swelling | Severely painful and swollen lymph node near neck. Lasted for seven days. |
| 40 | 2021-03-22 | lymph node swelling |
10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (...
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10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)
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| 40 | 2021-03-23 | anaphylactic reaction |
1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - ...
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1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.
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| 40 | 2021-03-23 | anaphylactic reaction | Anaphylaxia, breathing trouble |
| 40 | 2021-03-23 | lymph node swelling |
Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area a...
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Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.
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| 40 | 2021-03-23 | swelling face, lymph node swelling | Swelling of face and lymph nodes in neck, fighting of throat. |
| 40 | 2021-03-24 | lymph node pain, lymph node swelling |
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo...
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03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
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| 40 | 2021-03-25 | lymph node swelling |
Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was ...
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Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was mildly painful and the place of original shot was red and slightly raised.
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| 40 | 2021-03-25 | lymph node swelling | Fever of 101, swollen lymph nodule in armpit , body aches and stiffness of joints and limbs. |
| 40 | 2021-03-27 | anaphylactic reaction, peripheral swelling, swelling face |
Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swellin...
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Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.
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| 40 | 2021-03-27 | peripheral swelling |
Knuckles in my left hand became swollen like someone who has had rheumatoid arthritis for years. My ...
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Knuckles in my left hand became swollen like someone who has had rheumatoid arthritis for years. My knuckles have never swollen before. It?s been 2 weeks and they are still swollen with large knots on the first joint near the tip of my pointer, middle and pinky fingers. My right hand is not affected at all.
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| 40 | 2021-03-28 | lymph node swelling, lymph node pain |
Two left side swollen lymph nodes by collar bone. They are about the size of a dime and are very te...
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Two left side swollen lymph nodes by collar bone. They are about the size of a dime and are very tender and sore.
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| 40 | 2021-03-28 | peripheral swelling | Headache, nausea, chills, body aches, sore large swollen area in arm pit, sore arm |
| 40 | 2021-03-30 | lymph node swelling |
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t...
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Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
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| 40 | 2021-03-30 | peripheral swelling |
Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burn...
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Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.
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| 40 | 2021-03-31 | lymph node swelling |
Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. T...
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Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. The sensation was similar to receiving contrast dye for something like a CT scan. I was given Benadryl and my vitals were checked. I stayed at the clinic for a total of an hour. The sensation was fully gone about 90min after injection. I never felt short of breath or struggled to breath. I am experiencing pretty standard flu like symptoms within 12-24hrs after my second dose. Biggest and perhaps strangest side effect I feel now is all the lymph nodes in my right armpit are swollen and very sore.
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| 40 | 2021-04-01 | anaphylactic reaction |
Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and...
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Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.
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| 40 | 2021-04-04 | anaphylactic reaction |
Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min...
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Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min. after the shot, I experienced more severe symptoms of anaphylaxis. I was able to breathe but my airway was constricted and swollen. After arriving home, I called pharmacy but their pharmacists were out on lunch. My primary care doctor was closed (Good Friday). I waited until the pharmacist was back from lunch and they advised Benadryl (I took 50 g at 2pm) and to have someone with me for the next 24 hours. Symptoms improved some but by 5pm I still couldn't take a deep breath normally and was concerned about eating food. I went to the ER where they admitted me and administered Pepcid and dexamethasone at 6:22pm. After about an hour and a half, I felt better and was released. Once home, I ate food and that irritated my throat again so I kept an EpiPen nearby that evening just in case. The next morning I felt 100% with no side effects.
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| 40 | 2021-04-04 | swelling face |
Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Hea...
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Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Headache Neck pain
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| 40 | 2021-04-06 | swelling |
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ...
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dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
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| 40 | 2021-04-08 | swelling face, anaphylactic reaction |
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio...
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Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
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| 40 | 2021-04-12 | swelling face |
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati...
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had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
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| 40 | 2021-04-15 | swelling | Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit |
| 40 | 2021-04-21 | white blood cell count increased |
Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was t...
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Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was tested for COVID and discharged home and instructed to take acetaminophen. On 4/20, she returned to the ED with continued complaints including abdominal pain, nausea, and diarrhea. She also complained of dizziness when she stands, and that her skin and eyes were jaundiced. The patient was hypotensive and was not responding to IV fluids. She was started on vasopressors. She was found to be in acute liver and kidney failure. She was emergently intubated and ended up being transferred to hospital. Due to the nature of her condition, the above therapies were continued and CRRT was started due to acidosis. A bicarb drip was started and was continuous. Arrangements were made to transfer the patient to hospital once stable enough. It was thought that she was in HLH. She was also empirically started on hydrocortisone, later changed to dexamethasone. She was started on antibiotics - cefepime, Flagyl, and vancomycin. She has now been transferred to hospital. Outcome unknown at this time. 4/22
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| 40 | 2021-04-24 | anaphylactic reaction |
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ...
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anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
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| 40 | 2021-04-30 | lymph node swelling |
cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without mo...
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cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
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| 40 | 2021-05-12 | lymph node swelling, lymph node pain |
Painful and swollen lymph nodes under both armpits. Right side was significantly more painful. Pain...
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Painful and swollen lymph nodes under both armpits. Right side was significantly more painful. Pain spread into the right breast. Lasted for 5 days with strong symptoms, mild pain (right side only) continued for additional 3 days. Patient is a nursing mother.
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| 40 | 2021-05-13 | swelling |
Large hard bump on day 1, day 2 it became smaller but more spread out and red. Hot and itchy from da...
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Large hard bump on day 1, day 2 it became smaller but more spread out and red. Hot and itchy from day 1. Taken benadryl both days. Slight improvement.
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| 40 | 2021-05-14 | peripheral swelling |
then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the wo...
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then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
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| 40 | 2021-05-14 | peripheral swelling |
difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phon...
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difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.
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| 40 | 2021-05-15 | guillain-barre syndrome |
I was experiencing some muscle weakness in my lower extremity since Apr 3rd, one week after my first...
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I was experiencing some muscle weakness in my lower extremity since Apr 3rd, one week after my first shot of Pfizer on March 29th. The symptoms worsened over the next couple weeks limiting my mobility and resulting in unexpected falls. I could walk around the house and work sitting on my chair but was unable to climb up and down the stairs or run etc. I thought I had injured my quads during my regular workouts but during my annual check with my doctor on Tuesday Apr 20th we figured out it was a side effect of the Covid vaccine, where in the antibodies from the vaccine were actually attacking my healthy peripheral nerves resulting in muscle weakness and inability to move around comfortably and is called the GBS syndrome (Guillain-Barré syndrome). Unfortunately I had already taken the 2nd shot on Monday April 19th, before my doc?s appointment but fortunately we caught this in time to get me admitted to ER and do the tests to confirm GBS and my IVIG treatment started the very next day i.e. Wednesday April 21st till Sunday April 25th.
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| 41 | 2021-01-03 | swelling face |
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo...
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12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
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| 41 | 2021-01-04 | lymph node swelling |
after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to m...
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after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work
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| 41 | 2021-01-04 | lymph node swelling |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | swelling face |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual ...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.
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| 41 | 2021-01-05 | lymph node pain, lymph node swelling |
swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccinat...
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swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccination and lasted for about 48 hours
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| 41 | 2021-01-06 | anaphylactic reaction |
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i...
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Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
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| 41 | 2021-01-06 | lymph node swelling | Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches |
| 41 | 2021-01-06 | lymph node swelling |
Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness...
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Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.
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| 41 | 2021-01-07 | lymph node pain, lymph node swelling | I have developed a swollen/painful lymph node under my Lt armpit area. |
| 41 | 2021-01-07 | lymph node swelling |
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, li...
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Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
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| 41 | 2021-01-07 | lymph node swelling | Swollen supraclavicular lymph node left side |
| 41 | 2021-01-07 | swelling face |
sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a sp...
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sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.
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| 41 | 2021-01-07 | swelling, anaphylactic reaction | anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered |
| 41 | 2021-01-07 | swelling |
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la...
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Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
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| 41 | 2021-01-07 | swelling |
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection ar...
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Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 41 | 2021-01-08 | swelling | Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins. |
| 41 | 2021-01-08 | oral herpes |
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. To...
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Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
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| 41 | 2021-01-08 | swelling face |
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte...
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2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
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| 41 | 2021-01-08 | swelling | Itching palms ears head and eyes itching then escalated to itching all over and swelling |
| 41 | 2021-01-09 | lymph node swelling | Fatigue. Severe axillary lad and supraclavicular lad. Myalgia. Fever |
| 41 | 2021-01-09 | oral herpes |
Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. T...
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Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. The lesion was not changed.
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| 41 | 2021-01-10 | lymph node pain |
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a...
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I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
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| 41 | 2021-01-10 | lymph node pain |
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-...
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Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
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| 41 | 2021-01-10 | swelling face |
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ...
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cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 41 | 2021-01-11 | lymph node swelling |
12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of...
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12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of a base ball and ER and your lynodes had swollen. Gave you IVProphen and Tylneol Took a week in a half for swollen to go down.
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| 41 | 2021-01-11 | lymph node swelling | worsening of the rash developed tender/swollen supraclavicular lymph nodes |
| 41 | 2021-01-11 | lymph node swelling |
Swollen lymph node in left armpit; This is a spontaneous report from a contactable other healthcare ...
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Swollen lymph node in left armpit; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 04Jan2021 at 15:45 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported. The patient experienced swollen lymph node in left armpit on 05Jan2021 at 16:00. No treatment administered for the event. The patient did not have other vaccine in four weeks or other medications in two weeks. The patient also did not have Covid prior vaccination and had not tested for Covid post vaccination. The event was resolving.
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| 41 | 2021-01-12 | peripheral swelling, lymph node swelling |
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin...
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Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
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| 41 | 2021-01-12 | swelling face, lymph node swelling |
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ...
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24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
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| 41 | 2021-01-13 | anaphylactic reaction |
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn...
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Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
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| 41 | 2021-01-13 | swelling |
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea...
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severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-01-13 | lymph node pain, lymph node swelling |
right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue w...
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right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed
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| 41 | 2021-01-13 | lymph node pain, lymph node swelling | Large swollen gland on left side of neck. Sore gland.in left armpit area. |
| 41 | 2021-01-13 | lymph node swelling |
Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days pos...
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Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days post injection. Remaining enlarged still a week later. Fatigue as well.
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| 41 | 2021-01-13 | lymph node swelling |
My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches...
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My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.
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| 41 | 2021-01-13 | lymph node swelling |
I had a swollen lymph node approximately the size of a baseball that developed under my left armpit;...
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I had a swollen lymph node approximately the size of a baseball that developed under my left armpit; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EJ1685), intramuscular in the left arm on 18Dec2020 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included that the patient was diagnosed with COVID-19 prior to the vaccination. The patient did not have any allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medication in the two weeks prior to the vaccination. On 19Dec2020 14:00 PM, the patient experienced a swollen lymph node approximately the size of a baseball that developed under her left armpit. It took about 5 days to completely resolve. The patient did not receive any treatment for the event. The patient had not tested for COVID-19 post vaccination. The outcome of the event, swollen lymph node, was recovered, in Dec2020.
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| 41 | 2021-01-13 | lymph node swelling |
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facia...
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Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present.
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| 41 | 2021-01-13 | lymph node swelling |
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same p...
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sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
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| 41 | 2021-01-13 | peripheral swelling |
Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) ...
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Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) Eyelid edema & swelling in fingers - 37 hours (gone 72 hours)
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| 41 | 2021-01-14 | anaphylactic reaction |
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu...
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About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
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| 41 | 2021-01-14 | lymph node pain, lymph node swelling |
Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right b...
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Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; This is a spontaneous report from a contactable nurse. A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (anatomical location: arm right) from 07Jan2021 14:00 to 07Jan2021 14:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, pancreatitis, If-covid-prior-vaccination: Yes and allergies sulfa meds. Concomitant medication included paracetamol (TYLENOL) and metoprolol. The patient previously took codeine for allergies. The patient had first vaccine of BNT162B2 from 18Dec2020 to 18Dec2020 for COVID-19 immunization. On 08Jan2021 at 16:30, the patient had painful, very enlarged lymph nodes in right axilla, collarbone area, right side of neck and right breast. extremely painful and swollen. Started approx 26 hours after injection - came on suddenly. Outcome of the events was not recovered.
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| 41 | 2021-01-14 | lymph node pain |
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units un...
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Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
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| 41 | 2021-01-14 | lymph node swelling, lymph node pain |
Swollen painful lymph nodes left armpit; Swollen painful lymph nodes left armpit; This is a spontane...
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Swollen painful lymph nodes left armpit; Swollen painful lymph nodes left armpit; This is a spontaneous report from a non-contactable nurse reporting for herself. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 08:00 in left arm at single dose for COVID-19 immunization. Medical history included sulfa allergy from an unknown date and unknown if ongoing. Concomitant medication included buspirone hydrochloride (BUSPAR), lamotrigine (SUBVENITE) and quetiapine fumarate (SEROQUEL). The patient previously took amoxicillin and experienced allergies and received first dose of BNT162B2. The patient experienced swollen painful lymph nodes left armpit on an unspecified date. The outcome of the events was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-14 | lymph node swelling |
Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable ...
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Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received the first dose of BNT162B2 (lot number: ER5730), via an unspecified route of administration on 30Dec2020 08:30 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included metformin. The patient experienced swollen lymph node above collar bone on right side on 07Jan2021. The patient did not receive any treatment for the event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the event was not recovered.
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| 41 | 2021-01-14 | swollen extremities, swelling |
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,...
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Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
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| 41 | 2021-01-14 | peripheral swelling |
*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and s...
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*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and swelling on bilateral legs from upper thighs down to feet *Severe Itching Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm. Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
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| 41 | 2021-01-14 | swelling |
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ...
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Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
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| 41 | 2021-01-17 | peripheral swelling, lymph node swelling |
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nod...
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Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue
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| 41 | 2021-01-17 | swelling face, lymph node pain, lymph node swelling |
Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was ...
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Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am. patient is continuing to experience aches and pain still 1/18. Face was swollen and red until 1-17 pm. Lymph nodes in neck, collar bone and armpit on right side were swollen and sore. About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18
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| 41 | 2021-01-17 | swelling face |
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ...
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Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
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| 41 | 2021-01-17 | swelling face |
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain...
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Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
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| 41 | 2021-01-18 | lymph node swelling | Adnopathy Headache Intermittent fever O2 sat fluctuates between 84-92% Joint pain Fatigued |
| 41 | 2021-01-18 | swelling face |
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop...
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Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
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| 41 | 2021-01-19 | lymph node swelling |
Patient reported tightness in throat and swollen glands after injection. Rapid response called. Re...
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Patient reported tightness in throat and swollen glands after injection. Rapid response called. Returned to work with a follow up check by rapid response.
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| 41 | 2021-01-19 | swelling face |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who rec...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.
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| 41 | 2021-01-20 | guillain-barre syndrome |
Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manage...
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Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manager: Patient began experiencing symptoms of neuropathy and was admitted to the hospital as an inpatient on 1/18/21. Informed from neurologist that most likely Guillain-Barré syndrome resulted from vaccine and instructed to not receive 2nd dose of vaccine at this time.
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| 41 | 2021-01-20 | lymph node pain, lymph node swelling |
entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a ...
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entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 5730 and expiry date: unknown), intramuscular on 08Jan2021 11:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. There were no concomitant medications. Patient received the 1st dose on 21Dec2020 13:30 on the left arm. After the initial dose enlarged supraclavical lymph node enlargement on same side as vaccine dose-24 hour later-lasted 17 days after 2nd dose, same enlarged supraclavical lymph node within 2 hours of administration on 08Jan2021, followed by axillary lymph node pain starting at 8 hours (19:30) after dose, then groin lymph node pain and entire body joint pain at 12 hours (23:30) after 2nd dose, then ILI like symptoms for 36 hours. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 41 | 2021-01-20 | lymph node swelling, lymph node pain |
Swollen, tender lymph node to right armpit lasting all day Saturday. The swelling improved with hea...
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Swollen, tender lymph node to right armpit lasting all day Saturday. The swelling improved with heat application and was gone by Monday
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| 41 | 2021-01-20 | lymph node swelling |
itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears...
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itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
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| 41 | 2021-01-20 | lymph node swelling |
Approximately 4 days after first vaccine I began to develop lymphadenopathy in my right arm. Sympto...
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Approximately 4 days after first vaccine I began to develop lymphadenopathy in my right arm. Symptoms are still ongoing 7 days after they began.
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| 41 | 2021-01-20 | lymph node swelling |
Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphad...
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Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.
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| 41 | 2021-01-20 | swelling |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-21 | swelling face |
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-e...
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Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over
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| 41 | 2021-01-21 | swelling face |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-23 | lymph node swelling |
Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle ac...
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Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle aches, had to continuously stretch in bed, headache, some nasal congestion (resolved quickly), muscle aches continued in the morning but worsened around 11:30am on 1/24 and developed fever to 100.9. Muscle aches and fever lasted until taking Tylenol a few hours later.
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| 41 | 2021-01-23 | swelling face |
Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous...
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Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous adverse effect now three full days later
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| 41 | 2021-01-24 | guillain-barre syndrome |
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ...
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On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
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| 41 | 2021-01-24 | lymph node swelling |
enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous re...
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enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot 5730, expiration date unspecified), intramuscular on 21Dec2020 13:30 at single dose (left arm) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On an unspecified date, after initial dose, the patient experienced enlarged supraclavical lymph node enlargement on same side as vaccine dose 24 hours later and lasted 17 days. There was no treatment for the event. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Outcome of event was recovering.
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| 41 | 2021-01-24 | peripheral swelling |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-24 | swelling |
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun...
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This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
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| 41 | 2021-01-24 | swelling |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-25 | lymph node swelling | Swollen lymph node right armpit |
| 41 | 2021-01-25 | lymph node swelling |
aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spon...
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aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), intramuscular on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), fexofenadine hydrochloride (ALLEGRA). The patient had first dose of COVID-19 vaccine on 21Dec2020 intramuscular at right arm. On 12Jan2021, the patient experienced aches, muscle pain, low grade fever, and enlarged lymphnodes left supraclavicular region. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 41 | 2021-01-25 | lymph node swelling |
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma...
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Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
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| 41 | 2021-01-25 | peripheral swelling |
20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 mi...
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20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe
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| 41 | 2021-01-25 | swelling face |
About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, an...
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About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.
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| 41 | 2021-01-26 | lymph node swelling, swelling face |
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a...
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Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
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| 41 | 2021-01-26 | lymph node swelling |
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left...
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severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
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| 41 | 2021-01-27 | guillain-barre syndrome |
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St...
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5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
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| 41 | 2021-01-27 | lymph node pain, lymph node swelling | Pain and swollen Lymph node in right arm pit. |
| 41 | 2021-01-27 | lymph node pain, lymph node swelling |
Felt a little fatigue and little tired. It was lymphadenopathy - super clavicle area - above clavicl...
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Felt a little fatigue and little tired. It was lymphadenopathy - super clavicle area - above clavicle and neck (above collarbone area) - painful lymph node inflammation - and tender, marble size inflammation. Gradually subsided within four weeks. Today it is very small size now but almost back to normal. I had consulted with a physician because in this area it can be a cancer concern and he said to watch and wait.
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| 41 | 2021-01-27 | lymph node swelling | Throbbing lymphadenopathy on left side of body with chills |
| 41 | 2021-01-28 | lymph node swelling |
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T...
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weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
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| 41 | 2021-01-31 | lymph node swelling |
Severe Lymphadenopathy Supraclavicular lymphnodes axilla lymph node pain 10/10 radiating to neck ...
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Severe Lymphadenopathy Supraclavicular lymphnodes axilla lymph node pain 10/10 radiating to neck and back
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| 41 | 2021-02-01 | lymph node swelling | Chills, body aches, fever, swollen supraclavical lymph nodes on L side |
| 41 | 2021-02-01 | lymph node swelling |
body aches, muscle aches and swollen axillary lymph node under right arm (golf ball to tennis ball s...
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body aches, muscle aches and swollen axillary lymph node under right arm (golf ball to tennis ball size)
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| 41 | 2021-02-02 | lymph node swelling |
Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not...
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Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not sure when it appeared, but I noticed it on 1/20/22 in the evening due to pain in that location and on the front on my shoulder near injection site. My seatbelt was rubbing on it.
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| 41 | 2021-02-02 | swelling | Large swelling (about the size of a half baseball) Large Red area Hot to the touch Pain |
| 41 | 2021-02-03 | anaphylactic reaction |
Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxi...
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Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis
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| 41 | 2021-02-03 | guillain-barre syndrome |
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo...
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currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-03 | lymph node swelling |
fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary...
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fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares
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| 41 | 2021-02-04 | swelling face |
Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills;...
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Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-02-05 | lymph node swelling | Swollen lymph node in arm pit on the same side as injection site |
| 41 | 2021-02-07 | lymph node pain, lymph node swelling | Lymp nodes swollen in the neck area, underarm & clavicle area very tender & painful |
| 41 | 2021-02-07 | swelling face |
patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then pat...
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patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then patients other side of face started swelling. She felt like her throat was closing so we administered 1 dose of EpiPen 0.3mg at 12:30pm and called 911. EMS arrived on site 15 minutes later and took patient to ER.
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| 41 | 2021-02-09 | lymph node swelling, lymph node pain |
Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tig...
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Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tightness, some shortness of breath, rapid heart rate upon moving
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| 41 | 2021-02-09 | lymph node swelling, swelling |
I noticed a small lump near my collar bone on Saturaday 2/6/21. I looked up the lymph nodes in that...
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I noticed a small lump near my collar bone on Saturaday 2/6/21. I looked up the lymph nodes in that area, and then called my practitioners office on Monday. I was transfered to an Epidemelogy Nurse Answering service and received a call back shortly after from a Covid Vaccine Hotline nurse. By Monday, another smaller bump came out right next to the first one. I told her that I had swollen lymph nodes near my collar bone. She asked how big, I can feel all around the larger one with the tip of 2 fingers. She told me that it is normal to get swollen lymph nodes after any vaccine and I shouldn't worry about it. She told me to watch it and if it got larger or didn't go away, to call my practitioner again. Currently they lympth nodes haven't changed, but I have my booster in a week an a half, so I thought I should report this reaction, as it seems to be on the rare side of common side effects from the Pfizer vaccine from what I have read.
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| 41 | 2021-02-09 | lymph node swelling |
The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chill...
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The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
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| 41 | 2021-02-10 | lymph node swelling | Lymph node swelling in underarm and chest, size of grapefruit. |
| 41 | 2021-02-10 | lymph node swelling |
swelling of lymph nodes on same arm of injection site; This is a spontaneous report from a contactab...
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swelling of lymph nodes on same arm of injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 20Jan2021 14:30, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history and concomitant medications were none. Family Medical History Relevant to the adverse event: Patient's mother has bad allergies and knows she is contraindicated to this vaccine, but patient has never experienced any allergic reaction to anything. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 30Dec2020 1:30 pm, at a single dose on the left arm for COVID-19 immunization (age at vaccination: 41-year-old). The patient was administered her first dose the vaccine on 30Dec2020. She was administered her second dose of Pfizer COVID-19 Vaccine 20Jan2021, completing treatment. On 23Jan2021 08:00, three days after receiving the second dose of the vaccine she experienced swelling of lymph nodes on same arm of injection site. She reported onset of swollen lymph nodes in left arm 23Jan2021 which is ongoing. The swollen lymph nodes are present in the same arm that she was administered both first and second doses. She looked on the CDC website and did not know that this was a reported a side effect of the vaccine. She assumes it will go away. She called to clarify if she should tell her healthcare provider about this or if there are any recommendations regarding this event. She has taken some Motrin to help with the swelling. The event did not require a visit to the emergency room of physician's office. Therapeutic measures taken as a result of the adverse event included Motrin. Outcome of the event was not recovered. The patient assessed the event as non-serious. She does believe the event was potentially caused by the vaccine.
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| 41 | 2021-02-10 | swelling face | Itchy mouth, swollen face, itchy scalp, itchy ears |
| 41 | 2021-02-11 | swelling | Itchy, redness, swelling, for 10 days. fatigue, dizziness, presyncope ongoing 3 weeks later |
| 41 | 2021-02-12 | lymph node swelling | Localized enlarge lymph nodes/hypertension |
| 41 | 2021-02-14 | anaphylactic reaction |
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: ...
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Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
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| 41 | 2021-02-15 | swollen extremities | Pain in Arm; Pain and swelling below right arm pit; Headache; Nausea |
| 41 | 2021-02-16 | peripheral swelling |
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war...
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Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.
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| 41 | 2021-02-18 | anaphylactic reaction | Anaphylaxis |
| 41 | 2021-02-19 | peripheral swelling |
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night c...
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Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
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| 41 | 2021-02-20 | lymph node swelling |
Headache and body ache and tiredness started 8 hrs after. 48 hrs later swelling and severe pain in ...
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Headache and body ache and tiredness started 8 hrs after. 48 hrs later swelling and severe pain in armpit. Alternating Tylenol and ibuprofen and still feel pain.
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| 41 | 2021-02-21 | lymph node swelling |
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg...
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Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
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| 41 | 2021-02-21 | lymph node swelling |
Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and ver...
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Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.
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| 41 | 2021-02-24 | swelling face |
After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I aw...
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After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.
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| 41 | 2021-02-25 | lymph node swelling | Palpitations, swollen lymph nodes under my left armpit and general malaise the day after the vaccine |
| 41 | 2021-02-28 | swelling face |
Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult ...
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Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.
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| 41 | 2021-03-01 | lymph node swelling, lymph node pain |
I began having pain in the lymph nodes in my right under arm, then started experiencing stiffness in...
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I began having pain in the lymph nodes in my right under arm, then started experiencing stiffness in my neck, and today noticed a swollen node above my collar bone on the right as well. It is painful to touch and is radiating pain in my throat, right ear, and neck around the node.
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| 41 | 2021-03-01 | swollen extremities |
The arm pit got swollen up and the whole left side of the body started aching really badly. Could n...
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The arm pit got swollen up and the whole left side of the body started aching really badly. Could not move around and got headache and nausia too. That is still continuing tiil date.
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| 41 | 2021-03-01 | swelling face |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | lymph node pain, lymph node swelling |
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l...
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Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
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| 41 | 2021-03-02 | swelling face |
Filler swelling (face); This is a spontaneous report received from a contactable other healthcare pr...
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Filler swelling (face); This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9265, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 17:00, at single dose, for covid-19 immunization, at a public health department. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown) received at 41 years of age, via an unspecified route of administration on the right arm, on 08Jan2021 17:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 31Jan2021, the patient experienced filler swelling (face) (pending clarification). It was unknown if treatment was received for the event. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
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| 41 | 2021-03-05 | lymph node swelling |
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine...
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My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the clinic at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
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| 41 | 2021-03-06 | swelling face |
Patient was waiting in the parking lot when she notified the attendant that sensation of right faci...
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Patient was waiting in the parking lot when she notified the attendant that sensation of right facial fullness. No other respiratory distress, shortness of breath or any other s/s noted by RN assessment. Pt states she forgot to notify of allergy to shellfish Benadryl 25 mg given PO. Instructed to seek medical attention if she has further problems. Patient states that she is going to take another dose of Benadryl later today. States feels better. No further complications. VS Stable
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| 41 | 2021-03-07 | peripheral swelling, swelling face |
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief...
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o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
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| 41 | 2021-03-07 | swelling |
Several bug bites that I had started to itch incredibly and swelled into welts. The injection site i...
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Several bug bites that I had started to itch incredibly and swelled into welts. The injection site itched too and was hard. My scalp psoriasis also itched a lot. All of this was Saturday, with night being the worst. The bug bites still itch but less than before. I believe this histamine reaction is related to six wasp stings I got in August 2020. I had a bad reaction to the stings. I have been using a prescription topical steroid ointment on the bites since Saturday, which I got for the wasp stings.
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| 41 | 2021-03-08 | lymph node swelling |
Swelling of the lymph nodes in the left arm and axillary area. Extreme fatigue. Fever of 101 on Marc...
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Swelling of the lymph nodes in the left arm and axillary area. Extreme fatigue. Fever of 101 on March 6 for approximately 12 hours. Bone pain. Severe headache.
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| 41 | 2021-03-09 | swelling face |
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th...
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I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
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| 41 | 2021-03-10 | anaphylactic reaction |
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T...
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ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
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| 41 | 2021-03-11 | anaphylactic reaction | Anaphylaxis, swollen throat, itchy lips, hives. |
| 41 | 2021-03-11 | lymph node pain, lymph node swelling | Swollen lymph nodes under armpit going into left breast, very painful and tender |
| 41 | 2021-03-11 | peripheral swelling |
Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe...
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Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe pain on injected arm, headache, muscle ache, joint pain, chills, stiff neck and shoulders with possibly inflamed lymph nodes.
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| 41 | 2021-03-14 | lymph node swelling, peripheral swelling |
In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness...
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In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness/fatigue Headache Muscle pain Chills Fever Nausea Armpit pain Lymph nodes swelling (size of an egg) discomfort with arm movements Itchiness Lack of appetite Pain in shoulder blade
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| 41 | 2021-03-16 | lymph node swelling |
45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken any...
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45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken anything between the shot and time of the itching. I did about 20 minutes after the shot have a headache, severe arm pain, and then later that evening I had body aches, and the lymph node under my arm swelled up. I am still having the arm pain, swollen lymph node and itching and its 5 days later. I have been taking my already prescribed allergy medications as well as Benadryl and Claritin as advised by my doctor.
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| 41 | 2021-03-16 | swelling | Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days |
| 41 | 2021-03-17 | axillary mass | Lump in the armpit, discovered 5 days post vaccination |
| 41 | 2021-03-20 | lymph node swelling |
lymph nodes underneath the left armpit were swollen; This is a spontaneous report from a contactable...
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lymph nodes underneath the left armpit were swollen; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in the left arm on 12Feb2021 at 08:45 (Batch/Lot Number: EL9261) at 41-years-old as a single dose for COVID-19 immunisation; administered in a hospital. The patient's medical history was reported as none; no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1686, Administration time:08:45, intramuscularly, Left arm, Dose number:1) for COVID-19 immunisation on 22Jan2021 at 41-years-old. On 13Feb2021 at 07:00, after the second dose, the patient experienced: lymph nodes underneath the left armpit were swollen (non-serious). There was no treatment provided. The clinical outcome of the event, Swollen lymph nodes, was not recovered. The patient was not tested for COVID post vaccination.
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| 41 | 2021-03-21 | lymph node pain, lymph node swelling |
woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. A...
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woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. Area was tender, not discolored or warm to touch. Irritation the more I moved around. swelling was soft and pliable, no hardness. Monday morning swelling had decreased significantly. Email my care team on Sunday, Monday response was that swelling may have been attributed to the vaccine and I should file a report with CDC. No other symptoms other than soreness at injection site and body aches that lasted 24 hours.
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| 41 | 2021-03-22 | swelling face |
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec...
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Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
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| 41 | 2021-03-23 | swelling |
Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minut...
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Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
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| 41 | 2021-03-24 | lymph node swelling |
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back...
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5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
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| 41 | 2021-03-25 | lymph node pain, lymph node swelling |
Large swollen, tender lymph node in Right axilla 6 days after first shot 2/2/21 confirmed by ultras...
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Large swollen, tender lymph node in Right axilla 6 days after first shot 2/2/21 confirmed by ultrasound 2/9 second shot, in opposite arm, no adverse events, but right axilla lymph node still large and swollen
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| 41 | 2021-03-25 | lymph node pain, lymph node swelling |
Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 day...
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Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 days after injection. Ongoing as of 3/26/221
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| 41 | 2021-03-25 | lymph node swelling | Painful swollen enlarged lymph node in left armpit |
| 41 | 2021-03-25 | lymph node swelling |
Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so s...
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Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.
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| 41 | 2021-03-26 | lymph node pain, lymph node swelling | Right lymph node in neck swelling/pain. Right ear pain |
| 41 | 2021-03-26 | lymph node swelling |
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left a...
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Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
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| 41 | 2021-03-26 | swelling face |
Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Pa...
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Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.
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| 41 | 2021-03-28 | peripheral swelling |
No immediate reaction ? 6 days later in the middle of the night I woke with diarrhea, extremely itch...
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No immediate reaction ? 6 days later in the middle of the night I woke with diarrhea, extremely itchy hands and feet (red and swollen), that was followed by an extremely quick onset of fever with sweating and dizziness. SEVERE stomach/gut cramps. I took two Tylenol, drank a bottle of water, used a heating bad on my back, a JOVI patch on my stomach and a cold wet towel on my neck and chest. After 40 minutes symptoms had curbed enough to sleep. Woke at 8:00am hands are still itchy and swollen, headache , fatigue and mild stomach cramps.
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| 41 | 2021-03-29 | lymph node pain, lymph node swelling |
I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe...
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I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe symptom was a sore throat that persisted the entire time. The second dose I didn't get any cold like symptoms, but my left arm was so sore, it sent pain along my back, neck and leg on the left side. The left underarm lymph node is severely swollen and hurts like hell. It's a little better the 3rd day after the 2nd shot, but it's still visibly swollen to look at and very tender to the touch.
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| 41 | 2021-03-29 | swelling |
Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and m...
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Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and moodiness, lack of appetite for several days after the shot
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| 41 | 2021-03-29 | swelling |
-yellow and green bruising -lump under the skin -warmth to touch -itchiness Treatment is ice packs ...
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-yellow and green bruising -lump under the skin -warmth to touch -itchiness Treatment is ice packs twice a day for 15 minutes at a time. Also, taking Ibprophen.
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| 41 | 2021-03-30 | lymph node swelling, lymph node pain |
Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31...
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Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31/2021. Sore arm at injection site for first 3 days. Lymph nodes behind right ear swollen and painful starting 3/30/2021.
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| 41 | 2021-03-30 | peripheral swelling |
Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper o...
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Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper on my armpit every time I moved, swelling of my left breast along with pain and sensitivity. After icing, I got it to go down but it was twice the size as normal, both of my hands and forearms being swollen every morning I wake up. The pain in my armpit has subsided but my breast is still very painful. Right after the vaccine for 3-5 days- chills, fever of 99.9-102.4, diarrhea, migraine headaches, lameness, and lethargic
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| 41 | 2021-03-31 | anaphylactic reaction |
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens...
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Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
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| 41 | 2021-03-31 | lymph node swelling |
After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours la...
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After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours later. I woke up with a burning sensation in between my Shoulder blades, a fever, sweats, chills and body aches and severe joint pain. That started around 4:00am and was better around 1:00pm, but around 3:00pm noticed my lymph nodes felt swollen and my right arm pit was sore. Around 8:00pm, started to also feel achy again.
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| 41 | 2021-04-01 | peripheral swelling |
sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination tr...
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sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination treated with tylenol and ibuprofen, suggested warm compress as well
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| 41 | 2021-04-01 | swelling face |
22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambu...
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22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambulance reported and assisted patient, BP 124/86, pulse 99, BS 108 and EKG normal; no meds given, transported to the nearest hospital by ambulance due to continued altered mental status possible stroke.
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| 41 | 2021-04-02 | swelling |
angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/ti...
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angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-04-02 | lymph node swelling | Headache, 100+ fever, swollen lymph node, injection site redness and swelling, diarrhea, lethargic |
| 41 | 2021-04-02 | swelling |
Both inner thighs have been itching since about a week after first shot. 6 days after the second sh...
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Both inner thighs have been itching since about a week after first shot. 6 days after the second shot both inside thighs have softball size red, swollen patches that itcha and burn.
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| 41 | 2021-04-03 | peripheral swelling |
sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable cons...
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sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious. Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-04-04 | anaphylactic reaction |
45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that adm...
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45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that administered vaccine. Red splotchy chest, red ears, still dizzy and nauseous. Was admitted to ER where patient had 200/120BP and 140 pulse. Patient diagnosed with anaphylactic response to covid19 vaccine.. Epinephrine administered. Pepsid AC, Prednisone, and IV fluids. Vitals normalized and patient discharted ~2 hours later and prescribed pepsid, prednisone, and anti-nausea medication.
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| 41 | 2021-04-04 | oral herpes | Aches, Chills, constant sleep, throwing up, headache, foggy head, cold sores |
| 41 | 2021-04-11 | swelling |
Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, ...
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Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, difficulty in breathing, coughing and gagging while in our observation tent. Client was brought inside by wheelchair to our emergency area for further evaluation. Client was answering questions, pulse ox read 100%, pulse 106. Client had increased complains of tightness in throat, was coughing. 4:11 pm- 0.3 Epi pen given in right thigh. Lot # OFM534, exp: 9/20222. Call made to 911. Client then lost consciousness, eyeballs were fluttering underneath lids. Sternal rub- did rouse client, but then she became unconscious again. Daughter then reported a history of allergy to MRI dye, Pulse 110, 2 L O2 started. Client remained unresponsive, but was breathing normally. 415- call to Dr to assess whether Benadryl should be given or not- since client was unconscious. 415 shaking/chills began, and daughter reported history of non-epileptic seizures, but none since 2019. 416pm EMS arrived- IV started and seizure #2 witnessed by EMS. Seizure meds given per EMS- client transported to hospital.
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| 41 | 2021-04-17 | anaphylactic reaction |
extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contact...
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extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 41 | 2021-04-17 | swelling face, swelling |
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were ...
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delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
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| 41 | 2021-04-27 | anaphylactic reaction |
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react...
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asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-04-27 | swelling face |
Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. ...
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Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. Diagnosed with Bells Parsey about 8 days after receiving first dose.
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| 41 | 2021-04-27 | swelling |
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling ar...
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She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
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| 41 | 2021-04-28 | anaphylactic reaction |
Anaphylaxis. EMT and ambulance used at vaccine site. Hospitalization necessary. Two doses of epineph...
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Anaphylaxis. EMT and ambulance used at vaccine site. Hospitalization necessary. Two doses of epinephrine and steroids needed.
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| 41 | 2021-04-30 | peripheral swelling | My arm grew a large bump and now at hospital |
| 41 | 2021-05-03 | swelling face |
Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the l...
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Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell's Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell's Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.
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| 41 | 2021-05-07 | swelling face |
urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood ...
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urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
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| 41 | 2021-05-07 | swelling |
left axillary swelling 12 days post vaccination for 3 days, no pain; injection site pain; This is a ...
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left axillary swelling 12 days post vaccination for 3 days, no pain; injection site pain; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246) at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included Hypertension (HTN), Anxiety, Attention deficit hyperactivity disorder (ADHD). No Known allergies. Patient is not pregnant. Concomitant medication was not reported. First injection, 12Jan2021, injection site pain 1 day post vaccine (13Jan2021) and left axillary swelling 12 days post vaccination (24Jan2021) for 3 days, no pain. No covid prior vaccination. No covid tested post vaccination. Outcome of injection site pain was not recovered and outcome of left axillary swelling is unknown. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-05-10 | peripheral swelling |
Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was...
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Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was to sick to check. This was followed by intense muscle cramping in my chest due to the high fever. I had migraines several times a week that have last lasted until the 2nd dose (today 5/10/2021). Left arm also swelled to almost double the normal size for about 3 days. Post shot fatigue lasted about a week. I checked with an allergist and they said this was a strong immune response because I had had Covid previously, and not an allergic reaction. They also said that my second dose reaction should be less strong.
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| 41 | 2021-05-14 | peripheral swelling |
Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased w...
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Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-05-18 | lymph node swelling |
a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable c...
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a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration, in left arm on 09Mar2021 10:15 (age at the vaccination 41-years) as first dose single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included potassium citrate taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. Patient received within 2 weeks of vaccination: Anticoncep, bifllex, wate way. It was reported that 10 days after first dose, a lump came out close to my neck, lymph node type on 19Mar2021 03:00 PM. Patient did not receive treatment for the event. The outcome of the event was unknown.
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| 41 | 2021-05-18 | swollen extremities |
Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight ...
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Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight gain of 2 pounds overnight; Rash on chest; Rash on chest, possibly due to tape (dermatitis contact); Heart palpitations; Oxygen saturations dropped to 85% on room air; Diarrhea; This is a solicited report based on information received by Pfizer. A contactable consumer reported that a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 03Mar2020 to an unspecified date at 0.041 ug/kg, then at 0.045 ug/kg with therapy dates unspecified, and then at 0.049 ug/kg with therapy dates unspecified, for primary pulmonary arterial hypertension; and macitentan (OPSUMIT) on 11Jan2021, orally from 11Jan2021 at 10 mg, 1x/day for primary pulmonary hypertension. Medical history included ongoing primary pulmonary arterial hypertension. Concomitant medication included sildenafil citrate. On 15Jan2021, the patient had a blood clot in neck. The patient was hospitalized from 15Jan2021 to 16Jan2021 due to the blood clot in neck. It was reported that on 15Jan2021, which is 10 months 13 days after initiating IV Remodulin, the patient was hospitalized due to blood clot in her neck. The patient went to the emergency room on 15Jan2021 and she was planned to be admitted to change her catheter, later she was hospitalized on the same day and her Remodulin central line was changed as per the prior plans of getting the catheter changed. The patient was discharged on 16Jan2021. The patient then had a rash to her chest (dermatitis contact previously reported) that started on 20Jan2021. The patient believed it was from the original dressing that was placed after her catheter was replaced. The rash to left chest around her Remodulin catheter line (dermatitis contact previously reported) was also reportedly itchy at night. On an unknown date in 2021, the patient's oxygen saturations dropped to 85% on room air (oxygen saturation decreased). The patient continued to have rash on her chest (dermatitis contact previously reported). On 29Jan2021, 10 months 27 days after initiating IV Remodulin, the patient was in the emergency room due to increased shortness of breath, pressure on her chest, edema in her feet and a weight gain of 2 pounds overnight. All the tests were negative but during walking test, the patient's oxygen saturation dropped to 85% on room air. The patient was advised to wear mask continuously. 2 weeks after receiving the first COVID-19 vaccine, the patient had heart palpitations, shortness of breath, and chest pressure 2 weeks after receiving the first COVID-19 vaccine (dyspnoea and chest discomfort previously reported). The patient went to the ER (emergency room), had worked up and was seen by a pulmonologist, nothing was found, and the patient was released home. The prescribing physician's practice ordered her to wear oxygen (O2) continuously. The patient said that she only wears it when she leaves the house and at night and was fine. She felt this episode was related to the COVID-19 vaccine and was not receiving the second dose. The patient stated that her physician had took her off the Opsumit due to shortness of breath (dyspnoea previously reported). The events 'blood clot in neck', 'shortness of breath (dyspnea)', 'pressure on her chest', 'edema to her feet', 'weight gain of two pounds overnight' and 'heart palpitations', resulted in emergency room visit. The event, 'diarrhea', was controlled with diphenoxylate and atropine (LOMOTIL). The patient had a walking distance test on an unspecified date in 2021 (results were not provided) and weight was 209 lbs on an unspecified date in 2021. The events, shortness of breath (dyspnea)', 'pressure on her chest' and 'heart palpitations', was reported as serious (medically significant). The events rash on chest, and rash on chest possibly due to tape (dermatitis contact) had not resolved while the outcome of the rest of the events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Mar2021): This is a follow-up solicited report based on the information received by Pfizer. Additional information included medical history, suspect drug data, reaction details and clinical course details. Information on the batch/lot number has been requested. Follow-up (04May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the available information the events are most likely related to an intercurrent or underlying condition which is not related to the subject drug. There is a reasonable possibility that the drug contributed to occurrence of the event rash. The follow-up information received does not alter the previous company clinical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-01 | peripheral swelling |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-03 | swollen extremities |
After patient received an injection, patient developed fever, body aches, body chills, and injection...
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After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
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| 42 | 2021-01-03 | swelling face | Lip and facial area swelling tow days after receiving vaccine. |
| 42 | 2021-01-04 | lymph node swelling |
I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node...
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I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that
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| 42 | 2021-01-04 | lymph node swelling |
Lymphadenopathy on left axilla and elbow; This is a spontaneous report from a contactable nurse (pat...
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Lymphadenopathy on left axilla and elbow; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 at 11:45 (at the age of 42-years-old) as a single dose for Covid-19 vaccination. Medical history included cold urticaria and iritis from an unknown date. The patient did have allergies to the medications Sulpha, levaquin, cipro, and macrobid. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 08:00, the patient experienced Lymphadenopathy on left axilla and elbow. Therapeutic measures were not taken for the Lymphadenopathy on left axilla and elbow. The clinical outcome of the event Lymphadenopathy on left axilla and elbow was recovered on an unknown date in Dec2020. Information on the lot/batch number has been requested.
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| 42 | 2021-01-04 | swelling face |
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st...
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Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
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| 42 | 2021-01-06 | lymph node swelling |
Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on da...
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Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on day 9 progressing to mild lymphangitis by day 11 extending to mid arm. Resolved by day 20 without any treatment
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| 42 | 2021-01-06 | swelling |
Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphe...
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Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine
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| 42 | 2021-01-07 | anaphylactic reaction |
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi ...
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Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
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| 42 | 2021-01-07 | lymph node swelling, axillary mass | Lymph node swelling right axillary |
| 42 | 2021-01-07 | lymph node swelling |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | swelling face |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-08 | lymph node swelling, axillary mass |
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w...
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2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
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| 42 | 2021-01-08 | lymph node swelling | Lymphadenopathy of left axilla and left side of neck |
| 42 | 2021-01-08 | swelling | Rash and swelling around mouth, eyes, and behind ears |
| 42 | 2021-01-09 | lymph node swelling, swollen extremities |
Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enl...
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Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.
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| 42 | 2021-01-10 | lymph node swelling, lymph node pain |
About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down...
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About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
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| 42 | 2021-01-10 | lymph node swelling |
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai...
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Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
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| 42 | 2021-01-10 | peripheral swelling, swelling face |
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, alon...
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Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
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| 42 | 2021-01-10 | peripheral swelling | Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain. |
| 42 | 2021-01-11 | lymph node swelling, lymph node pain |
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo...
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joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 42 | 2021-01-11 | lymph node swelling | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | lymph node swelling |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccin...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches . symptoms began 9am on 1/9/21 and lasted 24 hours. utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
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| 42 | 2021-01-11 | lymph node swelling |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | swollen extremities |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, ...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, had a PCP visit in clinic, off work for 3 days and prescribed anti-inflammatory. Fever, aches, chills, headaches, began 1/9/21 at 9am. Resolved within 24 hours. used tylenol as bottle dosage. Low grade fever until 1/10/21 at 3pm. used aleve as bottle dosage.
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| 42 | 2021-01-12 | lymph node swelling | Large painful lump under right arm in the armpit about breast level. |
| 42 | 2021-01-12 | lymph node swelling |
Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report f...
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Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | lymph node swelling |
Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 ...
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Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 1600 noticed under arm swelling and discomfort - thinking it's lymphadenophathy just on left side. Took ibuprofen and no changed as of 1/13 am
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| 42 | 2021-01-12 | lymph node swelling | Crushing joint pain began late evening on 1/10/21 with swollen lymph nodes under the arms. |
| 42 | 2021-01-12 | swelling face |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | swelling |
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an...
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wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
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| 42 | 2021-01-13 | lymph node pain |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | lymph node swelling |
Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is o...
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Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is on the right side. No other findings
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| 42 | 2021-01-13 | lymph node swelling |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | lymph node swelling |
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (...
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Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
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| 42 | 2021-01-13 | swelling face |
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia...
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Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
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| 42 | 2021-01-14 | axillary mass |
Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare pro...
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Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 26Dec2020 17:00 (reported as 5:00 PM) at single dose on the right arm for COVID-19 immunisation. Medical history included asthma, thyroid cancer 2 years ago (2019) and shellfish allergies. The patient's concomitant medications were not reported. The patient previously took gadoxetate disodium (EOVIST) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. The patient experienced right swollen painful lump in armpit on 30Dec2020. It was unknown if treatment was received. The event resulted in doctor or other healthcare professional office/clinic visit. The event was assessed non-serious. Outcome of the event was recovered with sequel on an unspecified date (reported as "Recovered with lasting effects"). The patient has not been tested for COVID-19 since the vaccination. Information about lot/batch number has been requested.
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| 42 | 2021-01-14 | lymph node pain, lymph node swelling | fatigue and very swollen tender lymph node under left arm -same arm as shot received |
| 42 | 2021-01-14 | lymph node pain, swelling, lymph node swelling |
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ...
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I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
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| 42 | 2021-01-14 | lymph node pain |
Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a...
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Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiry date not reported), intramuscular in the right arm on 04Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included norethisterone (CAMILA). The patient previously took erythromycin and experienced allergies. On 10Jan2021 at 2:00, the patient experienced bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
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| 42 | 2021-01-14 | lymph node swelling, lymph node pain |
Swollen lymphnode approx 1 inch in diameter with swelling around the node approximately 2 inches in ...
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Swollen lymphnode approx 1 inch in diameter with swelling around the node approximately 2 inches in diameter. Pain. Was directed by my PCP,s walk-in clinic to report.
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| 42 | 2021-01-14 | lymph node swelling |
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that...
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Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
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| 42 | 2021-01-14 | lymph node swelling |
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O...
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Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
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| 42 | 2021-01-14 | peripheral swelling, lymph node swelling, swelling |
2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those e...
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2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those effects went away low grade fever, aches, but had a knot axillary lymph node, and my arm hurt worse then the swelling spread to my chest and neck. No trouble breathing. I went to the ER because the swelling was getting worse and they did a CT scan and gave me IV fluids. The CT scan revealed swollen lymph nodes.
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| 42 | 2021-01-14 | swelling face |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | swelling | Swelling red tender and very itchy. |
| 42 | 2021-01-16 | lymph node swelling |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-16 | swollen extremities, peripheral swelling |
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor...
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Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
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| 42 | 2021-01-17 | lymph node swelling |
Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was hi...
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Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was highest documented), arm pain in the arm I got the shot. I took Tylenol every 6 hrs for about 36 hrs. My fever "broke" and didn't return in the middle of the night on day 2. After that (so on day 2) my arm is still sore and I developed a red swollen, itchy rash about the size of my fist on my shoulder. I also have lymphadenopathy in the arm pit area that is making the whole arm and down that side sore and painful.
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| 42 | 2021-01-18 | lymph node swelling |
24 hours from injection she developed an 'apple' sized swelling of her left axillary lymph nodes whi...
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24 hours from injection she developed an 'apple' sized swelling of her left axillary lymph nodes which is painful and visible. No fever, redness or red streaking
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| 42 | 2021-01-18 | swelling |
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi...
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mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 42 | 2021-01-19 | lymph node pain, lymph node swelling | Swollen lymph node under left arm- dime size, hard to touch, tender to touch |
| 42 | 2021-01-19 | lymph node swelling |
Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infec...
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Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events "Tested positive for Covid/had the (Covid) infection" (coded to Drug ineffective / COVID-19) and swollen lymph nodes and BNT162B2 vaccine cannot be completely excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-19 | swelling | Pt with pain and swelling of the axilla that started about 12 hours after vaccine administration. |
| 42 | 2021-01-20 | lymph node swelling, lymph node pain |
Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swoll...
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Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.
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| 42 | 2021-01-20 | lymph node swelling | Body aches, shaking chills, joint pain, fever and left underarm lymph node enlarged |
| 42 | 2021-01-20 | peripheral swelling |
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu...
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Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
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| 42 | 2021-01-21 | lymph node swelling |
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axill...
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Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up left bicep into axilla
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| 42 | 2021-01-21 | swollen extremities, swelling face, lymph node swelling |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | peripheral swelling |
AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. ...
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AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. BY 10PM, TEMP CHILLS ALONG WITH FATIGUE. TOOK ADVIL.
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| 42 | 2021-01-22 | anaphylactic reaction |
Patient was under the 15 minute post-vaccination observation period when she presented with signs an...
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Patient was under the 15 minute post-vaccination observation period when she presented with signs and symptoms consistent with an anaphylactic reaction. Facility administered Benadryl, then an EpiPen, and called 9-1-1. Patient was brought to the hospital.
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| 42 | 2021-01-24 | swelling |
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ...
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No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
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| 42 | 2021-01-24 | lymph node swelling |
I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. ...
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I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.
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| 42 | 2021-01-24 | lymph node swelling |
I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph...
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I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph nodes on my left side, on my neck, on my chin and hey were tender and mobile. I consulted with my PCP who ordered some labs but all came normal.
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| 42 | 2021-01-24 | lymph node swelling |
Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my col...
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Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my collarbone and on my neck and on the side of my neck on the left side, they were tender and mobile. They got considerably smaller in a week but it took about a 2 weeks and one of them went away I still feel the others. Consulted with PCP who ordered labs. All normal results.
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| 42 | 2021-01-24 | swelling face |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-25 | lymph node swelling, lymph node pain |
Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left ...
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Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left posterior cervical) x 72 hours
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| 42 | 2021-01-25 | peripheral swelling | Itchiness throughout body, swollen shots on wrists and under feet, tiny dots on arms Now resolved |
| 42 | 2021-01-26 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 42 | 2021-01-29 | peripheral swelling |
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha...
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45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
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| 42 | 2021-01-30 | lymph node pain, lymph node swelling |
1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke t...
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1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke to low grade temp, pain, swelling, red injection site, headache; rest of the day tiredness, chills, muscle & joint pain, nausea. Taking Tylenol for pain 1/31/21 awoke to low grade temp, tiredness and enlarged right under arm lymph node, size of an egg, very sore, injection site remains red, tender to touch and swollen, taking Tylenol for pain As of 12:49p no temp
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| 42 | 2021-01-30 | swelling |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-01-31 | peripheral swelling | Body aches, fever = 101.5, swelling in arm, soreness in arm |
| 42 | 2021-01-31 | swelling, lymph node swelling, lymph node pain |
Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen....
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Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen. No redness at site or other symptoms noted.
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| 42 | 2021-02-01 | lymph node swelling |
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache,...
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13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.
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| 42 | 2021-02-01 | swollen extremities, peripheral swelling |
Reported to me over the phone:The night of the vaccination the left arm became very painful and swol...
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Reported to me over the phone:The night of the vaccination the left arm became very painful and swollen. The next day the swelling continued into armpit, noticed chills from waist down and a decrease in ROM with weakness.
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| 42 | 2021-02-02 | lymph node pain, lymph node swelling |
1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was use...
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1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was useless. I had muscle weakness and joint pain down to my wrist. I had to do old physical therapy exercises, ice pack on upper arm, and took tylenol (really wanted to take advil). Saturday evening: I discovered my lymph gland was swollen and very sore under my left arm. Took a hot shower and it helped. As long as I don't wear a regular bra it's ok. Sore to touch or if I moved my arm a lot. Tylenol (again with the advil)and heating pad. Still sore today. Creeps me out. I also, slept all day Saturday. Took a long nap Sunday. Went to the clinic on Monday, back to another clinic on Tuesday-Tuesday was when I had the extreme exhaustion. I napped for 3 hours in the afternoon and was so tired and woozy when I woke up. I had brain fog. Couldn't concentrate or care about much for awhile. Today, I slept in, and feel fineat the moment. Waiting to see if I have that nap exhaustion thing. I plan to walk some and go pick up some Vitamin C and Zinc supplements today.
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| 42 | 2021-02-03 | lymph node swelling |
Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). ...
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Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) solution for injection, via an unspecified route of administration on left arm on 16Jan2021 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. Patient has no known allergies. There were no concomitant medications. Patient was not pregnant. The patient received the first dose on 28Dec2020 (lot number: EK5730). Patient did not receive other vaccine in four weeks. Patient has no other medications in two weeks. The patient experienced left axillary lymphadenopathy on 17Jan2021 21:00. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was recovered. No follow-up activities are needed. No further information is expected.
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| 42 | 2021-02-04 | lymph node swelling |
Swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable con...
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Swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported a 42-years-old female patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 ) , via an unspecified route of administration on 19Jan2021 at SINGLE DOSE right Arm for covid-19 immunisation. The first dose bnt162b2 was received on 28Dec2020 for covid-19 immunisation. Medical history included severe allergies, hypothyroidism. There were no concomitant medications. The patient experienced swollen lymph nodes on 20Jan2021. The patient has done no treatment for the swollen lymph node, not even applying heat. The outcome of event was unknown.
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| 42 | 2021-02-08 | anaphylactic reaction |
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous...
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anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-08 | peripheral swelling |
After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noti...
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After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noticed swelling and redness on my left arm where the shot was administered. It itches really bad. I scratched it several times and then put rubbing alcohol on it to ease the itchiness. Currently my left arm is still red and swollen and itchy.
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| 42 | 2021-02-11 | lymph node pain, lymph node swelling, swelling |
I experienced swelling and tenderness to my lymph nodes and left axilla after receiving my first dos...
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I experienced swelling and tenderness to my lymph nodes and left axilla after receiving my first dose injection. I experienced large swelling up my neck , left side radiating to my shoulder blade. I experience a large lymph node which was swollen and very painful touch.
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| 42 | 2021-02-11 | lymph node swelling |
I experienced a ball size lymph node under my left arm which was very painful to touch. I also devel...
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I experienced a ball size lymph node under my left arm which was very painful to touch. I also developed chills and body aches.
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| 42 | 2021-02-11 | lymph node swelling |
I started having increased pain under my left arm that increased to some chest discomfort, body ache...
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I started having increased pain under my left arm that increased to some chest discomfort, body aches, low-grade fever. When I woke up the morning of the 8th I had a swollen lymph node the size of a baseball under my left arm.
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| 42 | 2021-02-14 | lymph node swelling |
Started my period five (5) days early - have a very regular cycle Swollen lymph nodes under left arm...
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Started my period five (5) days early - have a very regular cycle Swollen lymph nodes under left arm - arm vaccine was given in
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| 42 | 2021-02-14 | lymph node swelling | developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0. |
| 42 | 2021-02-15 | lymph node swelling | Swollen lymph nodes on my left armpit and left clavicle. |
| 42 | 2021-02-15 | white blood cell count increased |
Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) PO...
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Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment
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| 42 | 2021-02-16 | lymph node swelling |
Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at ...
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Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at 8am 1/10 . took Acetaminophen 1000mg for fever, headache, body aches, and weakness in extremities , increased fluids. Noticed a swollen sub clavicular lymph node on the left side That grew to the size of an almond. Migraine started at 11am same day. Took PRN Maxalt for Migraine and slept the rest of the day. Next day (1/11) slight headache that waxed and waned the rest of the day. Fever of 100.1 by 2:30 that same afternoon. Took Acetaminophen and fever resolved by the next day. Was seen for lymph node a week later by PCP and sent for an ultrasound. On 2/5 was scheduled for biopsy but on Ultrasound the lymph node had decreased in size from 2cm to 1.5cm on its own. Decided to hold off. Lymph node is now normal in size
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| 42 | 2021-02-18 | lymph node pain, lymph node swelling, swollen extremities |
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just...
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About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
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| 42 | 2021-02-18 | lymph node swelling, lymph node pain |
Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with...
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Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of neck. 2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
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| 42 | 2021-02-18 | lymph node swelling |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-18 | lymph node swelling |
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to b...
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Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
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| 42 | 2021-02-19 | lymph node swelling |
For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redn...
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For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redness at injection site ( walnut sized), 1 day only post injection: mild fever, chills, muscle and joint pain, fatigue
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| 42 | 2021-02-19 | lymph node swelling | Lymph node swelling in left armpit, fatigue, injection site pain, redness and swelling |
| 42 | 2021-02-20 | lymph node swelling | Swollen lymph nodes, underarm righ side |
| 42 | 2021-02-23 | anaphylactic reaction |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-23 | swelling face |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-23 | swelling face |
Pt was waiting in parking lot after receiving injection. Notified attendant that she was experienci...
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Pt was waiting in parking lot after receiving injection. Notified attendant that she was experiencing sensation of right facial "fullness" . RN's x 2 arrived at pt's car to assess and monitor. Denied shortness of breath or any other adverse symptoms. Vital signs taken - see below. Pt reported to RN that she had "forgotten to report" alleric response to shellfish. Benadryl 25 mg administered po and RN continued to monitor. Pr reported no further progression of swelling and was allowed to leave lot after 20 minutes. Stated she was going to her grandmother's house and would take another 25 mg of Benadryl on arrival there. RN instructed to seek medical attention immediately (ED or call 911) if sx progress.
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| 42 | 2021-02-24 | peripheral swelling |
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2...
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Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
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| 42 | 2021-02-26 | lymph node swelling |
I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatig...
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I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatigue, and swollen lymph node under my right arm. For about 4 hours, I could barely move because I was in so much pain. These symptoms continued, but after the four hours, was a little better. I still had significant symptoms for another day and a half. The symptoms slowly decreased until gone. I was off of work for 3 days. No treatment outside of OTC Tylenol, Aleve, ice pack, and rest.
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| 42 | 2021-02-26 | swelling face |
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm...
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Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
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| 42 | 2021-02-28 | lymph node swelling |
Patient has a history of Hodgkins Lymphoma with radiation to mediastinum/chest (2012) and high risk ...
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Patient has a history of Hodgkins Lymphoma with radiation to mediastinum/chest (2012) and high risk for breast cancer. Found to have asymptomatic left axillary lymphadenopathy on screening mammogram and subsequent US.
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| 42 | 2021-03-01 | peripheral swelling |
Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues...
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Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021. Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started. 1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working. Still having persistent numbness in left arm. Arm swelling. CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
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| 42 | 2021-03-02 | lymph node swelling |
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down bo...
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tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
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| 42 | 2021-03-03 | lymph node swelling, lymph node pain |
Swollen lymph nodes on right breast near armpit. Sore. Tender. Has been there for a couple of days s...
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Swollen lymph nodes on right breast near armpit. Sore. Tender. Has been there for a couple of days so far.
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| 42 | 2021-03-04 | lymph node swelling |
Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours...
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Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours. Then weak following 24 hours. 5days after had menstrual period start even though had just ended prior 2 days prior.
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| 42 | 2021-03-04 | lymph node swelling |
Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes ...
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Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes on left side. All symptoms began about 24hrs post vaccine. Swollen lymph nodes and near breast , below armpit stayed very sore and swollen for 5 days. All other symptoms were gone after about 24 hrs (48hrs post vaccine). Treated with ice, cool compress, probiotic, ibuprofen.
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| 42 | 2021-03-04 | lymph node swelling | Swelling and discomfort in left underarm lymph node, fever, body aches |
| 42 | 2021-03-05 | guillain-barre syndrome |
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a...
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Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
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| 42 | 2021-03-10 | lymph node pain | Pain in areas where lymph nodes exist- arm pits, groin, malaise, aches in joints, and nausea. |
| 42 | 2021-03-11 | lymph node swelling |
Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just...
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Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just about 30 seconds swollen lymph node under right arm - persisting on day 3 post injection brain fog - lasted 2 days
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| 42 | 2021-03-14 | lymph node pain |
significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant ...
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significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen. Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
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| 42 | 2021-03-14 | peripheral swelling |
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injec...
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Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
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| 42 | 2021-03-15 | lymph node swelling |
Received mammogram on 3/1/21 that came back as abnormal on right side. Repeated mammogram and got ul...
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Received mammogram on 3/1/21 that came back as abnormal on right side. Repeated mammogram and got ultrasound on 3/12/21 that confirmed enlarged right lymph nodes. I was told it was most likely due to the Covid-19 vaccine being administered on that side, and that I needed to return in three months for follow up imaging.
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| 42 | 2021-03-15 | swelling face |
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND...
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WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
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| 42 | 2021-03-15 | swelling |
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic ...
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Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
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| 42 | 2021-03-17 | lymph node pain | Burning sensation up neck and head after vaccine; severe pain in left arm in underarm area; fatigue |
| 42 | 2021-03-17 | lymph node swelling |
After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2n...
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After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2nd dose I got a rash of tiny bumps starting around my neck and then spread across my entire body including my scalp. I had inflamed lymph nodes and a cyst near the lymph node was inflamed. The rash continued. I went to my family dr and she gave me 4 days of 20mg prednisone. That helped some. After I finished the medication the rash was healing and then I started having hives that covered my entire body. I am also having 'hotspots' that flare up daily. I have had at least 25 hotspots. my skin stays severely dry no matter what I try. I went back to the dr when the hives started and she gave me a heavy taper down series of prednisone. while it has helped some my body still has hotpots, under the skin is prickly, tingly, and my skin acts like it has been sunburned is is peeling off. I have sores and raw spots randomly over my body. I am also using benadryl to help.
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| 42 | 2021-03-18 | anaphylactic reaction |
Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, ...
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Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, followed by Epinephrine 10minutes after Benadryl. EMS was called at that time and patient was transferred to higher level of care via ambulance.
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| 42 | 2021-03-18 | lymph node swelling, lymph node pain |
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoi...
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Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
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| 42 | 2021-03-18 | lymph node swelling |
Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14...
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Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,
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| 42 | 2021-03-19 | peripheral swelling |
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ...
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Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
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| 42 | 2021-03-21 | lymph node swelling, lymph node pain |
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ...
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lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-03-21 | lymph node swelling |
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and e...
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Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow. my right arm (injection site) is red, swollen, tender and warm to touch"
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| 42 | 2021-03-22 | anaphylactic reaction |
Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated...
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Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.
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| 42 | 2021-03-22 | swelling face |
90 minutes after vaccine administration, patient developed hives over neck and face and severe itchi...
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90 minutes after vaccine administration, patient developed hives over neck and face and severe itching on face, neck, and scalp, as well as a significant lump on the right side of neck; the following morning, severe facial swelling in cheeks and around eyes that made it difficult to open eyes; facial swelling and itching has improved but is still present (as of today, 3/23/21, four days after vaccine); lump on neck is still present but is smaller; patient has been taking Zyrtec, Benadryl, Tylenol, and topical cortisone cream.
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| 42 | 2021-03-23 | lymph node swelling |
swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontane...
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swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontaneous report from a contactable Other Health Professional. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201), intramuscularly, on 20Feb2021 at 12:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included obesity, eustachian tube dysfunction. The patient is allergic to grass (fescue). Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), intramuscularly, on 30Jan2021 at 12:00, intramuscularly in the right arm. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "None." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 15:00 the patient experienced Injection site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-24 | lymph node swelling |
1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an i...
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1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an ice pack for the lymph nodes.
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| 42 | 2021-03-24 | peripheral swelling |
Left upper arm, arm pit, left upper quadrant swelling. Left Breast increased to twice normal size. ...
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Left upper arm, arm pit, left upper quadrant swelling. Left Breast increased to twice normal size. Swelling continued for 4 days and slowly subsided.
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| 42 | 2021-03-25 | lymph node swelling | Hard lump behind left ear (same side as injection site) |
| 42 | 2021-03-25 | lymph node swelling | Arthritic inflammation, headache, visibly swollen lymph nodes under right arm |
| 42 | 2021-03-26 | lymph node swelling | Swollen lymph nodes - left collarbone Back ache Tiredness |
| 42 | 2021-03-26 | swelling face |
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s...
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In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
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| 42 | 2021-03-27 | lymph node swelling |
?Pfizer-BioNTech COVID-19 Vaccine EUA? Pain started 4 days after, just above and the the right of g...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? Pain started 4 days after, just above and the the right of gential area, groin. 8 days later I had a swollen and painful lymphnode and red bumps appeared nearby and on my back. On day 9 a doctor diagnosed it as Shingles. The pain continues to increase.
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| 42 | 2021-03-27 | peripheral swelling |
Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing...
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Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing one day after she got vaccinated at pharmacy. She has swelling, redness, and pain on the affected site. She was advised to take Benadryl, avoid scratching area. She can also apply cortisone cream instead of scratching area. She was told to monitor and report any symptoms that occur.
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| 42 | 2021-03-28 | swelling |
Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on...
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Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on the morning, I saw that the clear bandaid had some blood on it. Later on, I noticed that the bandaid was coming off, when I removed it, it was filled with clear liquid. The amount was to the point that it soaked my bandaid that it was coming off. At this point, I do not know how much of the vaccine was injected in me or how much of it leaked out. Symptoms post vaccination: soreness and a large bump, injection site is red, warm, and pain to touch.
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| 42 | 2021-03-29 | peripheral swelling |
Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. Thi...
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Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. This was sudden in onset without any trauma. Pulses were intact in both feet. Due to the swelling there was tenderness on the balls of the toes and it was painful to touch. Motrin 200 mg as needed helped relieve it for 1-2 days and then it would recur. The symptoms were present for 6 weeks and thereafter resolved.
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| 42 | 2021-03-30 | lymph node swelling |
I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day aft...
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I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day after the first shot/injection, and has been swollen to the touch, a sore and irritated sensation at times. It is the size of an almond, and has not gotten any better.
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| 42 | 2021-03-30 | swelling |
Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. ...
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Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. About 20 mins later, I felt tingling and numbness in my upper lip as well as just above my lip. Consulted with the pharmacist who administered the shot as well as an on-line nurse about adverse side effect. I was instructed to take Benedryl, which I did (37.5 mg). It didn?t do anything to address the tingling. It has been four plus days since the vaccination and the right side of my upper lip feels swollen.
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| 42 | 2021-03-31 | peripheral swelling |
This may be within the normal bounds but wanted to make sure that I reported this as continued resea...
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This may be within the normal bounds but wanted to make sure that I reported this as continued research is ongoing with the Covid-19 vaccines. I received the Pfizer vaccine 2nd dose on March 29 around 12:15 pm. At the injection site I developed a light bumpy rash. My upper arm also was swollen -- the best way to describe the feeling is as if someone stitched a small ball into my skin and took a bat to it. Made it very difficult to work (typing), and lifting/using arm. I also had a mild sore throat for 48 hours post vaccination.
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| 42 | 2021-04-01 | lymph node swelling |
Large swollen lump on left quad in the pm on 4/1. Chills, fever, body aches, headache at 4am on 4/2 ...
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Large swollen lump on left quad in the pm on 4/1. Chills, fever, body aches, headache at 4am on 4/2 and onward through the day.
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| 42 | 2021-04-01 | peripheral swelling | Vomiting, swelling of left hand, nausea. BP 118/81 (pulse 82), O2 sat 100%. |
| 42 | 2021-04-01 | peripheral swelling |
Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and...
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Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and tingling/numbness/discomfort in left arm within 5 minutes after injection in left arm. (She was negative for lip or oral mucosa swelling, voice change, SOB, rash, visible flushing, urticaria) Her vitals remained stable and initial sx resolved spontaneously within 15-120 minutes apart from swelling (without erythema or induration) and tenderness on left medial anticube, which was treated with ice. Patient had normal ROM, strength of left arm. Patient was observed or 50 minutes and cleared by NP and MD to leave with instructions to FU with ED if return of symptoms. Arm swelling was resolving when called the next day.
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| 42 | 2021-04-03 | swelling face |
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel...
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i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
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| 42 | 2021-04-17 | guillain-barre syndrome |
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ...
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Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
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| 42 | 2021-04-24 | anaphylactic reaction |
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de...
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Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
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| 42 | 2021-04-26 | lymph node pain |
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we...
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Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
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| 42 | 2021-04-27 | lymph node swelling, lymph node pain |
Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sor...
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Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite
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| 42 | 2021-04-27 | swelling face | swelling of face, facial numbness |
| 42 | 2021-04-27 | swelling, lymph node swelling |
4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - ch...
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4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - chest pain (same day as cortisone injection) 4/24 - worsening swelling, pain with swallowing 4/25 - admitted to the hospital through the ED with erythemic rash to bilateral palms, bilateral feet, back; painful, not itchy; eye red; lip swollen; tongue pain and pain with swallowing
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| 42 | 2021-05-03 | lymph node swelling |
fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101...
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fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-05-05 | lymph node swelling, lymph node pain |
My 2nd vaccine injection was in April 26. The next day the lymph node at my collar bone was very swo...
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My 2nd vaccine injection was in April 26. The next day the lymph node at my collar bone was very swollen and tender. This continued for several days until May 4th when the lymph node was no longer visibly swollen or tender to touch; however, muscle soreness in my shoulders and neck, as well as a right sided headache, has unexpectedly set in.
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| 42 | 2021-05-07 | anaphylactic reaction |
flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever ...
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flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-05-07 | oral herpes |
I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is ...
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I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EL9269) (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccines received in four weeks. The patient previously took droperidol and experienced allergy; nortriptyline and experienced allergy. The patient was not diagnosed with COVID prior to vaccination. The patient was diagnosed with oral and genital herpes on 08Mar2021, which was a complete shock to the patient. The patient stated that it's some kind of side effect to the vaccine. The events required a visit to the doctor's clinic. The event was treated with an unspecified medication. The reporter considered the event as serious (disability). The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 20Mar2021. The outcome of the events was recovered with sequelae. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-03 | lymph node pain, lymph node swelling |
Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on ...
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Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on the third day but was most pronounced and painful on the fourth day.
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| 43 | 2021-01-03 | lymph node swelling | Noticed a little tension to supraclavicular area, then when palpated noticed the swelling |
| 43 | 2021-01-03 | swelling face |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-04 | peripheral swelling, lymph node swelling |
I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat....
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I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat. I also developed swelling on my right forearm that was hot to touch with pain. I used a heating pad as well on my right forearm and took Tylenol for two days-it resolved.
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| 43 | 2021-01-06 | anaphylactic reaction |
anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic ...
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anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.
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| 43 | 2021-01-06 | oral herpes |
14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next da...
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14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next day but head ache and low grade fever remain.
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| 43 | 2021-01-07 | swelling |
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac mo...
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Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
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| 43 | 2021-01-07 | swelling | Fever, Angioedema, SkinRash & Rash Narrative: |
| 43 | 2021-01-07 | lymph node swelling |
I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began ha...
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I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
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| 43 | 2021-01-07 | lymph node swelling |
Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous...
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Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
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| 43 | 2021-01-07 | lymph node swelling |
Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm...
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Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. "
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| 43 | 2021-01-07 | swelling |
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms ...
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One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
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| 43 | 2021-01-08 | lymph node swelling |
Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet h...
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Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.
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| 43 | 2021-01-08 | lymph node swelling |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever co...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)
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| 43 | 2021-01-08 | white blood cell count increased | Generalized edema, shortness of breath, change in taste |
| 43 | 2021-01-09 | swelling face |
Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benad...
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Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.
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| 43 | 2021-01-10 | lymph node swelling, lymph node pain | Axillary swelling, pain and tenderness in armpit. pain in finger joints. |
| 43 | 2021-01-10 | lymph node swelling |
injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to clos...
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injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful
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| 43 | 2021-01-10 | lymph node swelling | Left axillary lymphadenopathy, fatigue/body aches |
| 43 | 2021-01-10 | lymph node swelling | axillary adenopathy on injection side 48 hrs headache |
| 43 | 2021-01-10 | lymph node swelling | Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm |
| 43 | 2021-01-10 | swelling | Swelling, pain, muscle weakness, redness, heat |
| 43 | 2021-01-11 | swelling | urticaria angioedema |
| 43 | 2021-01-11 | peripheral swelling |
Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external ves...
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Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines
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| 43 | 2021-01-11 | swelling face |
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07...
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1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
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| 43 | 2021-01-11 | white blood cell count increased, anaphylactic reaction |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-12 | lymph node pain, lymph node swelling | Fever, mayalgias, fatigue, swollen and sore lymph node under right arm pit |
| 43 | 2021-01-12 | lymph node swelling, lymph node pain |
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has ...
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Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has prior hx of this): ambulance to hospital. Pt assessed & released same day. Pt is free from that symptom now. Also experienced painful knot under arm lasting 5 days
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| 43 | 2021-01-12 | lymph node swelling | Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness |
| 43 | 2021-01-12 | lymph node swelling |
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ...
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Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
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| 43 | 2021-01-13 | lymph node swelling |
My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body ac...
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My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body aches, and fatigue. The result of my mammogram and ultrasound confirm the swollen lymph nodes. If they are still the same in 3 months we will schedule a biopsy.
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| 43 | 2021-01-13 | lymph node swelling | Swollen lymph nodes |
| 43 | 2021-01-13 | peripheral swelling, swelling |
My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spont...
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My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
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| 43 | 2021-01-13 | swelling |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-14 | anaphylactic reaction |
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ...
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5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
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| 43 | 2021-01-14 | anaphylactic reaction |
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta...
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Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
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| 43 | 2021-01-14 | lymph node pain |
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node te...
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approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness. At present, large reddened area at and below injection site and lymph tenderness
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| 43 | 2021-01-14 | lymph node swelling |
tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; mu...
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tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 43 | 2021-01-14 | lymph node swelling |
On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenop...
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On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.
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| 43 | 2021-01-14 | peripheral swelling |
Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on...
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Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
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| 43 | 2021-01-15 | lymph node pain | 1/15/21 awoke with under right arm very tender (no redness) |
| 43 | 2021-01-15 | lymph node swelling | Rash, swollen lymph node, fever |
| 43 | 2021-01-17 | oral herpes | COld sores on bridge of nose near right eye |
| 43 | 2021-01-17 | swelling face |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-17 | white blood cell count increased |
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and...
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Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
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| 43 | 2021-01-18 | lymph node swelling |
received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, ...
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received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, temp=101.6. Severe chills 0400, diaphoresis. 0900 body aches, especially back and legs. swollen axillary lymph node on arm of injection. Began vomiting intermittently until 1630. two days post injection awoke fully recovered with exception of tender, swollen axillary lymph node on arm of injection.
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| 43 | 2021-01-18 | lymph node swelling |
intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibup...
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intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibuprofen and tylenol which exacerbated stomach ache. Then took sucralfate and esomeprazole and tylenol supp.
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| 43 | 2021-01-18 | lymph node swelling | Swollen Lymph node in left collar bone area about 1 inch around |
| 43 | 2021-01-18 | swelling face |
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts wo...
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Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
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| 43 | 2021-01-19 | anaphylactic reaction, swelling face |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | lymph node swelling |
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa...
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Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
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| 43 | 2021-01-19 | lymph node swelling |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-19 | swelling face | My right arm at injection site is swollen and hurts and my left side of my face is swollen. |
| 43 | 2021-01-19 | swelling |
Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and pred...
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Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and prednisone
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| 43 | 2021-01-20 | lymph node pain, lymph node swelling |
swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were ...
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swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
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| 43 | 2021-01-20 | lymph node pain, lymph node swelling |
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h...
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Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
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| 43 | 2021-01-20 | swollen extremities, lymph node swelling |
Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain s...
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Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain still 1/22, low grade fever ranging from 99.2-101 until only day after, headache still 1/22
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| 43 | 2021-01-20 | swelling | SWOLLEN UNDERARM, TENDER TO TOUCH ON THE SAME ARM AS THE INJECTION. |
| 43 | 2021-01-21 | lymph node swelling |
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; Th...
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swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
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| 43 | 2021-01-21 | lymph node swelling |
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp...
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I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
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| 43 | 2021-01-21 | lymph node swelling |
A mammogram is performed and the results showed left axillary lymph nodes with mild cortical thicken...
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A mammogram is performed and the results showed left axillary lymph nodes with mild cortical thickening
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| 43 | 2021-01-22 | lymph node pain |
Axillary Lymphadenitis. Lymph node is hard and painful. Large amount of fluid swelling protruding ou...
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Axillary Lymphadenitis. Lymph node is hard and painful. Large amount of fluid swelling protruding outwards from armpit. Larger than a golf ball but smaller than a baseball. Aching sensation.
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| 43 | 2021-01-22 | peripheral swelling |
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m...
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Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
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| 43 | 2021-01-23 | lymph node swelling, lymph node pain | Swollen/painful lymph node for 5 days |
| 43 | 2021-01-24 | lymph node pain, lymph node swelling |
Mild chills, fever and body aches for 24 hours - treated with ibuprofen Severe lymphadenopathy of le...
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Mild chills, fever and body aches for 24 hours - treated with ibuprofen Severe lymphadenopathy of left axillary region and upper left chest wall below collar bone - accompanied by pain and discomfort Pain lasted ~4-5 days. Swelling fully resolved on Day #8 after injection. Treated with ibuprofen and pillow under arm. 1 missed day of work
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| 43 | 2021-01-24 | peripheral swelling |
arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report fro...
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arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had a reaction after the vaccine. The first vaccine her arm was inflamed, and so swollen, she couldn't move it. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-24 | peripheral swelling |
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand...
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I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
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| 43 | 2021-01-25 | lymph node swelling |
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta...
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Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-25 | lymph node swelling |
SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGU...
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SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGUE, LOW FEVER, ACHES & CHILLS, HEADACHE
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| 43 | 2021-01-25 | swollen extremities |
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir...
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chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
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| 43 | 2021-01-25 | peripheral swelling |
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha...
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Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-26 | swelling face, swelling |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-27 | anaphylactic reaction | dyspnea, anaphalaxis |
| 43 | 2021-01-27 | lymph node pain, lymph node swelling |
Per patient: patient developed sore/swollen glands on neck on 1/23/2021 (morning after receiving vac...
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Per patient: patient developed sore/swollen glands on neck on 1/23/2021 (morning after receiving vaccine). Lymph nodes along clavicle on right side are swollen/sore as well. Patient went to provider's office on Monday (1/25/2021) for symptoms. Patient states that lymph nodes on neck are better today, but lymph nodes along clavicle on right side continue to worsen. Patient is in contact with her provider.
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| 43 | 2021-01-27 | swollen extremities |
Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began u...
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Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began upon waking morning after injection, and still present at this time (72 hours later). Area is tender to touch.
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| 43 | 2021-01-28 | swollen extremities | chills, body aches, nausea, swelling under left arm pit Had to take off work 01/28/21 no doctor |
| 43 | 2021-01-29 | peripheral swelling, lymph node swelling |
cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to ...
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cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
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| 43 | 2021-01-31 | axillary mass |
have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit ...
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have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit that is as big as fist. no redness to it.
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| 43 | 2021-02-01 | lymph node swelling |
Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved ...
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Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved by day three. Day 4 started having periods of extreme vertigo, this is happening more frequently and with more severity up to today 2/2/2021 woke with severe dizziness and nausea, fell over when rising from bed. continue to be very dizzy and nauseated
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| 43 | 2021-02-01 | lymph node swelling |
swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A ...
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swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 15Jan2021 at a single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) in Sep2020 for birth control. There was no history of all previous immunization with the Pfizer vaccine. The patient had no prior vaccination within four weeks. On 17Jan2021, the patient experienced swollen lymph node in the left arm pit which became really noticeable. She reported she feels like she looks deformed due to the swollen lymph node. She had bloodwork drawn about 1.5 weeks ago (Jan2021) but has not received the results from that yet. The event did not require emergency room or physician office visit. The patient was not hospitalized. Outcome of the event was not recovered.
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| 43 | 2021-02-01 | oral herpes |
Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient)...
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Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 08Jan2021 20:30 (08:30 PM) at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included allergies with mango. No other medical history. There were no concomitant medications (reported as "Other medications in two weeks: No"). No other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient received the first dose on 17Dec2020 03:00 PM (lot number: EH9899) on the right arm. The patient experienced cold sore (herpes labialis) on 11Jan2021 20:00 (reported as "08:00 PM"). No treatment was received for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-02-02 | anaphylactic reaction |
Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically res...
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Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
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| 43 | 2021-02-02 | lymph node pain | I have pain in my right axillary area, or lymph nodes. |
| 43 | 2021-02-02 | lymph node swelling |
Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's....
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Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's. ED notes as follows. Discharged in stable condition with a Holter monitor. Initial Vital Signs [02/02/21 0713] Blood Pressure 139/93 Heart Rate 126 Respiratory Rate 18 Temp 37.2 °C (98.9 °F) Temp src Oral SpO2 99 % 43 y.o. female who arrived to the emergency department for Palpitations and tachycardia. Patient states that the symptoms started approximately 545 this morning while getting ready for work. She states that palpitations started spontaneously with no inciting event. She denies chest pain or shortness of breath. She states that she felt the palpitations and looked down to her watch and showed a heart rate into the 190s to 220s. Upon arrival to the emergency department her heart rate is in the 190s. When she was brought back to the room, her heart rate was around 120-130. Still denying any chest pain or shortness of breath. She did receive her second for Covid vaccine yesterday. No reaction with the first vaccine. No changes in medication, caffeine intake. Denies smoking, drinking, drug use. No history of similar events. Father has a history of a heart block requiring pacemaker. Medical history of melanoma varicose veins but no cardiac or pulmonary history including pulmonary embolism.Patient is a nurse in the neurosurgical unit as one of the case managers During initial evaluation, patient was sitting in bed in no acute distress. Vitals signs stable tachycardia although better than initially arriving. Physical exam unremarkable. Labs indicate elevated D-dimer. We will proceed with CT PE. CT scan of scan shows no signs of PE there is evidence of left axillary adenopathy which is consistent with her vaccination yesterday. Upon repeat evaluation, patient was updated regarding lab and imaging results. Heart rate had improved greatly down to the 90s to low 100s. She was able to ambulate around without becoming grossly tachycardic, dizzy, lightheaded or shortness of breath. Unsure of exact cause of palpitations and tachycardia. Recommend outpatient monitoring with Holter monitor. Follow-up with primary care provider or cardiologist. Return to emergency department if symptoms return or new concerning symptoms occur. Treatment plan was discussed with the patient who was agreeable and exhibited understanding. Questions were answered to patient's satisfaction. Through shared decision making with the patient and the emergency medicine care team, we discussed and decided the patient is stable and ready for discharge. Patient remained hemodynamically stable in the emergency department. Patient was provided with verbal and written follow-up/discharge instructions and return precautions. Recommend follow up with PCP in 2-3 days for symptom re-evaluation and further management. Patient should return to emergency department if symptoms worsen or new concerning symptoms develop.
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| 43 | 2021-02-02 | peripheral swelling |
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sid...
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I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
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| 43 | 2021-02-03 | lymph node swelling, swelling |
woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) a...
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woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) and significant pain left axilla.; swollen axilla and golf-ball sized lymphadenopathy; swollen axilla and golf-ball sized lymphadenopathy; mild fever (100.4) in AM; This is a spontaneous report from a contactable physician who reported for herself. A 43-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL1283) Intramuscularly at left arm 15:15 on 17Jan2021 for Covid-19 immunization. Patient received her fist shot (Lot number EI0142) intramuscularly at left arm 06:45 PM on 27Dec2020. The patient had a medical history included factor V leiden, and Hashimotos thyroiditis. Patient had no known allergies. Concomitant medications included rivaroxaban (XARELTO), levothyroxine, rizatriptan benzoate (MAXALT). No other vaccines were taken within four weeks. 12 hours post vaccine (around 04:00 AM on 18Jan2021), patient woke with myalgias (left-sided) and significant pain left axilla. It was noted swollen axilla and golf-ball sized lymphadenopathy. Also, she had mild fever (100.4) in AM. The patient had no COVID prior vaccination and had no COVID tested post vaccination. The outcome of the events was unknown. Amendment: This follow-up report is being submitted to amend previously reported information: Laboratory test "mild fever (100.4)" as "Body Temperature" updated in lab data section in Patient tab.
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| 43 | 2021-02-03 | swelling face |
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd...
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Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
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| 43 | 2021-02-03 | swelling, lymph node swelling |
Swelling of lymph node in right armpit originally. Swelling and fluid spread - filling right side of...
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Swelling of lymph node in right armpit originally. Swelling and fluid spread - filling right side of body, across right collar bone, halfway down torso and slightly around the back. It also spread down the right arm halfway to elbow. The on-call nurse originally thought it could be cellulitis but after being told there was no redness or itchiness, she was unsure of the diagnosis and suggested to talk with the on-call doctor or go to the ER. The on-call doctor really had no idea as to what was going on. Once at the ER, the doctor checked with other doctors and read as much as he could about this type of reaction. Nothing he read matched up exactly with what was going on. He did note some swelling of lymph nodes had been reported but not to this extent. With all this being new, he suggested to go home and watch the swelling and come back if things got worse. For several days, there continued to be no redness or itchiness. The discomfort was only in the lymph node in the right armpit, with some slight pressure from the skin tightening around the fluid on the arm. Within a week, the welling was completely gone and the lymph node discomfort lasted a couple days more. I feel it necessary to note that I don't believe the shot was given in the correct location. As soon as the needle entered the skin, my thought was 'that is too high' and there was a pain like I have never felt with a vaccine before. That pain subsided shortly after the injection but it was several days before the injection site felt better. Now, two weeks later, I have a constant pain in my shoulder, slightly down my arm and into my collar bone area. There are also times when the pain throbs or shoots through as well. I believe this pain may be due to the placement of the shot, and not necessarily from the vaccine itself.
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| 43 | 2021-02-04 | anaphylactic reaction |
15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and m...
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15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED
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| 43 | 2021-02-04 | lymph node pain, lymph node swelling |
Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the ...
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Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the right side. Lymph node in right axilla sore, swollen and tender. Symptoms lasted 48 hours. Advil taken for symptoms.
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| 43 | 2021-02-04 | lymph node swelling |
Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess o...
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Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess of 7 days); This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 14Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine sodium (LEVOXYL), liothyronine, and sertraline. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 (lot number: EJ1685) at 09:30 AM, in the left arm for COVID-19 immunization when the patient was 43-year-old. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination nor was she tested since the vaccination. The patient experienced swollen lymph nodes, sensitive skin, body aches, muscle aches and pain, prolonged headache (excess of 7 days), all on 14Jan2021 at 03:00 PM with outcome of not recovered. There was no treatment received for the events. The events were reported as non-serious.
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| 43 | 2021-02-04 | lymph node swelling |
swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneou...
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swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20Jan2021 14:15 at SINGLE DOSE at Left arm for covid-19 immunisation . Medical history included basal cell carcinoma. Concomitant medication included l-arginine [arginine]. The patient experienced swelling of (most likely) lymph nodes in left armpit (same arm as vaccination) on 21Jan2021 17:00. No treatment for the event. The outcome of event was not recovered. Information on the lot/batch number has been requested.
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| 43 | 2021-02-05 | lymph node swelling | Lymph nodes swollen over neck and axil of the left side, pain and redness on the shot side . |
| 43 | 2021-02-06 | swelling |
Small redness around injection site then large red area 2-3 inches below injection site that is cont...
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Small redness around injection site then large red area 2-3 inches below injection site that is continuing to grow. Area is red warm and hard/swollen. Scratchy throat, rash on abdomen and back with no itch. Feel crappy.
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| 43 | 2021-02-09 | peripheral swelling |
Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night t...
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Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night the severity increased and started noticing red rashes. Went to ER Wed am and there were swelling noticed in palms and rashes through out the body.
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| 43 | 2021-02-09 | white blood cell count increased |
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy an...
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Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
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| 43 | 2021-02-11 | swelling face |
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre...
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After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
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| 43 | 2021-02-12 | lymph node swelling | Left arm pit really sore- swollen lymph nodes |
| 43 | 2021-02-14 | lymph node swelling | Body aches, mouth sores, swollen soar glands, difficulty swallowing |
| 43 | 2021-02-14 | lymph node swelling |
Fever, malaise - onset at 16h, relieved at 48h post-vaccine Left axillary lymph node swelling and di...
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Fever, malaise - onset at 16h, relieved at 48h post-vaccine Left axillary lymph node swelling and discomfort - onset at 24h post-vaccine, has not subsided
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| 43 | 2021-02-14 | swelling face |
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne...
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Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-16 | swelling face |
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu...
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pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
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| 43 | 2021-02-17 | lymph node swelling, lymph node pain |
Pain and swelling in my lymph node in left armpit; Pain and swelling in my lymph node in left armpit...
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Pain and swelling in my lymph node in left armpit; Pain and swelling in my lymph node in left armpit; On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL8982), via an unspecified route of administration at the left arm on 30Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. The patient has no other medical history. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization, on 13Jan2021 12:00PM at the left arm, lot number: EL3246 at the age of 43 years. On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021. On 01Feb2021 06:00 AM, the patient experienced pain and swelling in her lymph node in left armpit. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The events pain and swelling in my lymph node in left armpit recovered on Feb2021. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-02-17 | lymph node swelling | Lump under collarbone |
| 43 | 2021-02-17 | swelling |
Vaccine at lunch time. Slight headache and tired within the hour. Awful rash started At commut...
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Vaccine at lunch time. Slight headache and tired within the hour. Awful rash started At commute Home. Welts. Hives swelling. For days.
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| 43 | 2021-02-17 | swelling |
left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report f...
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left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received her first doe of bnt162b2 (BNT162B2 reported as PFIZER -BIONTECH COVID-19 VACCINE; lot number: Em9810; expiration date: unknown), via an unspecified route of administration left arm on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient has no medical history and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clarithromycin (CLARITIN), zinc, ergocalciferol (VIT D) and vitamins nos (MULTIVITAMINS reported as mtv). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 12:00 AM, the patient had left armpit in arm tender swollen. The events were non-serious, and no treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
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| 43 | 2021-02-18 | lymph node swelling, swelling |
I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I r...
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I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I received the first vaccine on 2/14/21 around 4:55 pm. 2/15-I awoke at 7am: sweating, headache, body aches/ pinging type sensation, fatigue, pain across my chest , no trouble breathing though. These are the same symptoms I had when I had Covid. 2/16 I was able to get out of bed, run errands, but still have headache, still feel achy, haven?t noticed a fever but I have had moments of sweating like one broke. Lymph nodes under my left arm are swollen and painful to touch. 2/17lymph nodes still very large and swollen, pings of 2/18: fatigue, weakness, 11pm- right arm became cold and numb like it was asleep, pinging muscle aches or more accurately pains where lymph nodes are located. Body seemed swollen overall too. 2/19: right arm and uncle still swollen and heavy Groin lymph area right side is painful today.
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| 43 | 2021-02-18 | lymph node swelling |
Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get o...
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Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get out of bed. Extreme weakness, joint pain, back and neck pain, swollen gland under left armpit, pain, headache, fever up to 102.5. 2/18/21 low grade temp. 99.9. joint pain, headache. Used Tylenol, 2 pills every 4 to 6 hours.
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| 43 | 2021-02-18 | swelling |
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficul...
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Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
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| 43 | 2021-02-20 | lymph node swelling, lymph node pain |
12 hours after injection: chills, fever started to elevate. 14-16 hours after =102° fever, fatigue...
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12 hours after injection: chills, fever started to elevate. 14-16 hours after =102° fever, fatigue, joint aches. Swollen lymph node in infected arm. Fever started to drop after 48 hours. Lymph node pain, joint pain, fatigue persists 3 days later.
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| 43 | 2021-02-22 | swelling | Swelling of the lips- angioedema |
| 43 | 2021-02-22 | lymph node swelling |
Had 1st dose 12/18/20, had 2nd dose 1/8/21. On 1/15/21 noticed right cervical lymph node swollen >5c...
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Had 1st dose 12/18/20, had 2nd dose 1/8/21. On 1/15/21 noticed right cervical lymph node swollen >5cm. After 3 biopsies , diagnosed with non Hodgkin's lymphoma 2/11/21
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| 43 | 2021-02-23 | anaphylactic reaction | Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe |
| 43 | 2021-02-23 | lymph node swelling |
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ...
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Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
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| 43 | 2021-02-23 | swelling face |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-24 | white blood cell count increased |
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv...
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Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
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| 43 | 2021-02-25 | lymph node swelling |
swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't co...
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swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
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| 43 | 2021-02-25 | swollen extremities |
Swelling and pain in right armpit started Thursday February 25 in the early afternoon. Causing pain...
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Swelling and pain in right armpit started Thursday February 25 in the early afternoon. Causing pain to radiate down arm. acetaminophen and cold packet to help with pain
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| 43 | 2021-02-26 | lymph node swelling | Lymph nodes swollen on my left side where I received the shot |
| 43 | 2021-02-27 | lymph node swelling |
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built ...
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New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot. About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
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| 43 | 2021-02-28 | lymph node swelling | Swollen lymph nodes in R armpit, generalized fatigue, 'fuzzy headedness' |
| 43 | 2021-03-02 | anaphylactic reaction |
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy...
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Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
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| 43 | 2021-03-02 | swelling face |
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci...
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Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-03-05 | peripheral swelling | Fever, Chills, muscle ache, joint pain, headache, fatigue, arm swollen |
| 43 | 2021-03-07 | lymph node swelling |
chills-started 4pm on 2/19 lasted until 10AM 2/20 muscle aches-started 12:00AM on 2/20 lasted until ...
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chills-started 4pm on 2/19 lasted until 10AM 2/20 muscle aches-started 12:00AM on 2/20 lasted until 10AM 2/21 Swollen lymph nodes-left armpit and behind head/neck area both sides started 2/20-lasted 3 days
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| 43 | 2021-03-08 | axillary mass |
felt a painful lump/mass under left arm (axillary) the day after receiving the vaccine 1/12/2021. I ...
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felt a painful lump/mass under left arm (axillary) the day after receiving the vaccine 1/12/2021. I had an office visit on 1/14*2021 because I continue to have arm pit swelling with tenderness. I was alternating between motrin or Tylenol around the clock for several days and pain was relieved with pain medication. Dr. provided breast examination and determined could be lymph node swelling caused by the vaccine and we should wait 1 more week for further eval. She said if swelling still there would order an ultrasound, luckily at day 5 sunday 1/17/2021 I finally felt no more swelling or pain. no further exams needed and a few weeks later heard on the news this situation was becoming more common with vaccine administration.
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| 43 | 2021-03-08 | swelling face |
Around ten minutes post injection PT experienced tingling throughout body, slight constriction in th...
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Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.
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| 43 | 2021-03-09 | anaphylactic reaction | Anaphylactic reaction, splotchy skin |
| 43 | 2021-03-09 | swelling face | Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness |
| 43 | 2021-03-12 | lymph node swelling, peripheral swelling |
left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath m...
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left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath my arm pit is swollen. Also had body aches and head ache through the night. That is better but the swollen arm and lymph node is not
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| 43 | 2021-03-13 | swelling face | Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue. |
| 43 | 2021-03-13 | swelling face |
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with...
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Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
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| 43 | 2021-03-14 | anaphylactic reaction |
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing...
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Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
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| 43 | 2021-03-15 | lymph node swelling, lymph node pain |
fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at i...
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fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at injection site 4 days
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| 43 | 2021-03-15 | lymph node swelling, white blood cell count increased | I exp swollen lymph nose on right clavicle. The swelling still there much smaller now |
| 43 | 2021-03-15 | lymph node swelling |
stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This i...
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stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-03-16 | lymph node pain, lymph node swelling |
Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulde...
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Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulder blades Nausea Fatigue All symptoms began roughly 12 hours after administration. Today is the fourth day, and symptoms are persisting.
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| 43 | 2021-03-18 | lymph node pain, lymph node swelling |
Painful swollen lymph node on left clavicle. Treatment has consisted of ice and naproxen. No change ...
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Painful swollen lymph node on left clavicle. Treatment has consisted of ice and naproxen. No change in outcome.
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| 43 | 2021-03-18 | peripheral swelling, lymph node swelling | Swollen arm and swollen lymph nodes under left arm |
| 43 | 2021-03-21 | swelling |
Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and...
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Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and red hands b/l. No SOB, throat swelling, itching, scratching, no tongue swelling. AAO x 3. Talking with no difficulty. No known allergies. Benadryl 25 mg PO was administered. She was monitored. No further symptoms.
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| 43 | 2021-03-22 | lymph node swelling, swelling |
Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ...
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Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ongoing . (3 months now.)
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| 43 | 2021-03-24 | guillain-barre syndrome |
Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A...
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Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Dec2020 07:30 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies as wine. Concomitant medication included loratadine (CLARITIN [LORATADINE]) 10 mg, as needed, daily for unspecified indication. On 23Dec2020 07:45 patient experienced Paresthesia tip of RIGHT little finger within 10 minutes of vaccine. Tachy arrhythmia, loss of function in RIGHT little finger/hand, and syncope 45 minutes after vaccine while driving. Tachycardia, hypertension, generalized weakness, and severe fatigue walking upstairs (persistent and worsened over several days). Loss of function/sensation RIGHT arm and RIGHT leg 8 days after vaccination. Symptoms persisted and worsened. Diagnosed with Guillain Barre Syndrome and POTS at follow up on 19Jan2021. She still have persistent weakness/paresthesias/neuropathy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Dec2020. Seriousness criteria for all events was hospitalization.The events Guillan Barre syndrome and syncope were medically significant. Outcome of the event Guillain Barre Syndrome was recovering. Outcome of the other events was unknown.
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| 43 | 2021-03-25 | swelling face |
Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. L...
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Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. Lips and lower face are becoming more swollen. I have no access to Health insurance so I will take a shower and some Benadryl, my only attainable recourse at this time.
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| 43 | 2021-03-26 | axillary mass, peripheral swelling |
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with...
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Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
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| 43 | 2021-03-26 | lymph node pain, lymph node swelling |
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th ...
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By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort. I do have a migraine as well, but I believe it is due to my mentrual cycle.
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| 43 | 2021-03-26 | swelling |
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,...
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Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
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| 43 | 2021-03-27 | lymph node swelling |
Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four d...
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Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four days post vaccine, lymph node under am is still very swollen, pain and soreness down arm still present.
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| 43 | 2021-03-27 | oral herpes | Massive cold sore outbreak 7 to 9 days after first shot |
| 43 | 2021-03-28 | lymph node pain, lymph node swelling |
On 3/20/2021 I received my annual mammogram. When leaving the facility, my left arm where I received...
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On 3/20/2021 I received my annual mammogram. When leaving the facility, my left arm where I received both vaccines started hurting the same as when I received both vaccines. By the end of the day I was not able to lift my arm above my head. I still have pain and swollen lymph nodes my left arm and near my left breast. I had swollen lymph nodes after 2nd vaccine which I received on 1/7/2021.
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| 43 | 2021-03-28 | lymph node swelling |
At the end of the first dose my Dr. ordered a CT scan for swollen Lymph nodes. The report from radio...
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At the end of the first dose my Dr. ordered a CT scan for swollen Lymph nodes. The report from radiology are showing enlarged lymph nodes located in the left side of my neck measuring at up 1.1 sonometers. They only found them on the left side where the vaccine was given. I was told to do self examinations and notify them if they get larger. I had a mild headache and soar arm after the vaccine.
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| 43 | 2021-03-28 | lymph node swelling |
Slight swelling, long lasting inflammation at injection site. Very swollen lymph node (5 days) unde...
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Slight swelling, long lasting inflammation at injection site. Very swollen lymph node (5 days) under arm on the side of the injection. Very painful (stabbing pain). General swelling of other lymph nodes as well, but less prominent. Fever starting 18 hours after second dose. Peak fever 101.7 from baseline of 98.4. Resolved in about 12-18 hours.
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| 43 | 2021-03-28 | lymph node swelling | Fever, chills, aches 18 hours after the shot. Swollen lymph node 24 hours after shot |
| 43 | 2021-03-28 | lymph node swelling |
There was some mild neck pain, almost like I slept wrong. I ended up with lymph nodes on the left si...
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There was some mild neck pain, almost like I slept wrong. I ended up with lymph nodes on the left side around my clavicle and base of my neck. You can feel them, small like dime size. I seen my Dr. and he ordered a CT scan.
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| 43 | 2021-03-29 | lymph node swelling | Lymph node swelling in left arm pit Muscle aches (back) |
| 43 | 2021-03-29 | lymph node swelling |
Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ...
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Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ball size knot in lymph nodes
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| 43 | 2021-03-29 | swelling | Swelling, redness & itching at injection location. "Covid Arm" |
| 43 | 2021-03-30 | lymph node swelling |
Swelling of the lymph node in left axilla; This is a spontaneous report from a contactable nurse (pa...
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Swelling of the lymph node in left axilla; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number:EK4176 Exp Date: not reported), via an unspecified route of administration on an unspecified date (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swelling of the lymph node in left axilla on 27Jan2021. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
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| 43 | 2021-03-30 | lymph node swelling |
swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report ...
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swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered. Information on the lot/batch number has been requested.
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| 43 | 2021-03-31 | lymph node pain |
Headache started approximately an hour after the injection. Chills and fatigue started the next even...
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Headache started approximately an hour after the injection. Chills and fatigue started the next evening after the injection. Sore/painful armpit/lymph node under left arm (same side as injection) started 2 days after the injection. The headache and chills were relieved by Tylenol.
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| 43 | 2021-03-31 | peripheral swelling |
Headache for 2 days Stiff neck for 4 days Swollen legs from calves down, especially my left ankle....
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Headache for 2 days Stiff neck for 4 days Swollen legs from calves down, especially my left ankle. Skin was tight & itchy. Swelling lasted for 2 days in right leg & 2 weeks in left leg
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| 43 | 2021-04-01 | lymph node pain |
30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became to...
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30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became totally numb. I mostly felt the numbness in the sides of my face and chin. This lasted for approx 1 hour and did not return. I didn?t notice swelling.
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| 43 | 2021-04-03 | swelling |
angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient ...
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angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 17:15 (at the age of 43years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced "uvula/soft palate/posterior oropharynx angioedema 5 days post vaccine" on 21Mar2021 (10:00AM). The adverse event resulted in Emergency room/department or urgent care. The patient was treated with Epinephrine, Benadryl, Solu-Medrol. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information and on the compatibility with the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-04-03 | swelling face |
Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. ...
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Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated. It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.
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| 43 | 2021-04-03 | swelling |
Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and pai...
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Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and painful to the touch.
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| 43 | 2021-04-04 | swelling face |
I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, a...
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I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, and my cheeks and under eye area as well.
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| 43 | 2021-04-11 | anaphylactic reaction | Anaphylaxis, acute respiratory distress, mild tongue edema |
| 43 | 2021-04-17 | anaphylactic reaction | Anaphylactic reaction that required a 3 day hospital stay with steroids and oxygen. |
| 43 | 2021-04-17 | lymph node swelling |
broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous repor...
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broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 25Mar2021 16:30 (Batch/Lot Number: ER8732) (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included benign brain tumor removal, seizures (previous seizures prior to surgery), penicillin (PCN) allergy and sulfa drugs allergy. Concomitant medications included topiramate (TOPAMAX), eletriptan hydrobromide (RELPAX), ergocalciferol (VITAMIN D) and ascorbic acid (VITAMIN C), all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient broke out with hives on her face and hands and had swollen lymph nodes in throat on 27Mar2021 08:00. The patient went to emergency room/ department or urgent care due to the events, broke out with hives on her face and hands and swollen lymph nodes in throat. The patient received antihistamine as the treatment for the events, broke out with hives on her face and hands and swollen lymph nodes in throat and the patient was also offered steroid but she declined it. The outcome of events, broke out with hives on her face and hands and swollen lymph nodes in throat, was recovering. No follow-up attempts are needed. No further information is expected.
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| 43 | 2021-04-22 | lymph node swelling |
Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after ...
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Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after injection) along with headache and swollen lymph nodes in neck/throat on Thursday night (7 days after injection). Still persisting on Friday morning and getting worse as I am typing this.
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| 43 | 2021-04-23 | swelling face |
Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left sid...
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Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3302), via an unspecified route of administration in left arm on 13Jan2021 10:00 as single dose and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En5318) via an unspecified route of administration in left arm on 04Feb2021 11:00 as single dose for COVID-19 immunization. Patient age was 43-years-old and was not pregnant at the time of vaccination. Vaccine was administered at the military facility. Patient medical history included sleep apnoea syndrome. The patients concomitant medication included melatonin taken for an unspecified indication, start and stop date were not reported. The patient experienced cheek swelling on left side of face with numbing of lip due to swelling with numbing of lip due to swelling on 25Jan2021. No other vaccine in four weeks. Emergency room/department or urgent care. No COVID prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.
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| 43 | 2021-04-30 | peripheral swelling |
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top...
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problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
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| 43 | 2021-05-03 | swelling face |
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself ...
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Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
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| 43 | 2021-05-05 | lymph node swelling |
Day 2-4 swollen glands in left side of neck Days 6-8 104 fever, chills, extreme body aches, vomiting...
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Day 2-4 swollen glands in left side of neck Days 6-8 104 fever, chills, extreme body aches, vomiting, diarrhea, headache, cough, abdominal pain when I cough.
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| 43 | 2021-05-09 | lymph node swelling |
Swollen lymph nodes under right arm close to chest, in armpit area. Very large!!! Very painful. Sore...
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Swollen lymph nodes under right arm close to chest, in armpit area. Very large!!! Very painful. Sore throat guessing enlarged lymph nodes as well. Very Achy joints all over body, especially legs.
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| 43 | 2021-05-10 | swelling face |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient recei...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient received Pfizer covid vaccine, experienced some lip swelling on the way home and stopped by another pharmacy and was given 2 pills of benadryl 25mg. Swelling went down, patient is fine. Reported by pharmacy manager.
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| 43 | 2021-05-11 | white blood cell count increased, lymph node swelling |
breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged sl...
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breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days. She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021. They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent. The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days. No follow-up attempts are needed. No further information is expected.
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| 44 | 2020-12-31 | peripheral swelling |
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ...
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After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
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| 44 | 2021-01-01 | c-reactive protein increased | Fever chills severe myalgia headache |
| 44 | 2021-01-01 | lymph node swelling, lymph node pain |
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly...
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Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
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| 44 | 2021-01-03 | lymph node swelling | Arm pain at injection site, fatigue, mild headache, swollen lymph nodes |
| 44 | 2021-01-03 | lymph node swelling | Swollen L armpit, medial, at same side of vaccine. Resolved in 2 days with ibuprofen |
| 44 | 2021-01-04 | lymph node pain |
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-1...
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Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.
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| 44 | 2021-01-04 | lymph node swelling, swelling |
L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular ar...
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L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular area; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: eh9899), intramuscularly on 22Dec2020 12:30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included ongoing hypertension, allergic to shellfish. Concomitant medication within 2 weeks of vaccination included losartan, hydrochlorothiazide, vitamin C [ASCORBIC ACID], colecalciferol (VITAMIN D), zinc, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced L armpit swollen/ L armpit lymph nodes swollen, sensation of heaviness left arm and painful scapular area from 23Dec2020 15:30. No treatment received for the adverse events. The outcome of events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
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| 44 | 2021-01-04 | lymph node swelling |
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te...
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pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
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| 44 | 2021-01-04 | peripheral swelling, swelling face, anaphylactic reaction |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-05 | lymph node swelling |
lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size...
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lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.
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| 44 | 2021-01-06 | lymph node swelling |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-07 | lymph node swelling |
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and he...
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Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
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| 44 | 2021-01-07 | swelling, peripheral swelling |
Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first fing...
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Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well
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| 44 | 2021-01-08 | axillary mass |
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling i...
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Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
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| 44 | 2021-01-08 | lymph node swelling | Headache, chills, joint and muscle pain, fever of 102, nausea, lymphadenopathy Lt Axilla. |
| 44 | 2021-01-08 | swelling face |
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli...
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1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
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| 44 | 2021-01-08 | swelling face |
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di...
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I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
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| 44 | 2021-01-09 | lymph node swelling |
Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor l...
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Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor lumpy. Area aches and appears to be growing in size
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| 44 | 2021-01-09 | swelling face |
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ...
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I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
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| 44 | 2021-01-09 | swelling face |
Face swelling 1st 6 hours. First night ( bilateral pinky fingers and right thumb) and every night th...
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Face swelling 1st 6 hours. First night ( bilateral pinky fingers and right thumb) and every night thereafter right thumb locked up during the night, then moves in trigger thumb motions when attempting to move. Goes away during day but reoccurs every night. Sudden onset the night of vaccination with no previous episodes. Dr appointment made 10 days later due to symptoms not getting better. Dr ordered bracing for wrist and thumb at night and 10 mg of meloxicam daily. Im on day 3 of tx. This was the first morning I woke with milder locking up and trigger thumb symptoms.
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| 44 | 2021-01-10 | lymph node swelling | Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection |
| 44 | 2021-01-10 | lymph node swelling |
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr...
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Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
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| 44 | 2021-01-10 | lymph node swelling |
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of...
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Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
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| 44 | 2021-01-10 | lymph node swelling | Redness, pain injection site, swollen armpit resolved |
| 44 | 2021-01-10 | lymph node swelling |
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar...
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1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
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| 44 | 2021-01-10 | swelling, lymph node swelling |
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r...
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Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
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| 44 | 2021-01-10 | swelling |
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those...
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Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
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| 44 | 2021-01-11 | swelling face |
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and...
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24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
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| 44 | 2021-01-11 | swelling face |
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ...
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On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
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| 44 | 2021-01-12 | lymph node swelling |
employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hou...
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employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hours post receiving second dose of covid 19 Pfizer vaccine on 1/7/2021 in right arm. When questioned the employee stated she also experienced the same mild swelling and tenderness of the armpit area lymph nodes with first dose of vaccine also. The first dose of vaccine was given 12/18/2020 at approximately 1600 in left arm and lymph node mild swelling and tenderness noted in left armpit the following evening. On both occasions the swelling and tenderness lasted 48-72 hours and occurred in the corresponding armpit of the arm which vaccine was administered
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| 44 | 2021-01-12 | swelling, anaphylactic reaction |
Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ...
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Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
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| 44 | 2021-01-13 | lymph node pain |
Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular ...
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Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular lymph node (left side- mildly tender), left sided neck pain, and left forearm tenderness that began almost 72 hours post vaccine. No fever. No other symptoms
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| 44 | 2021-01-13 | lymph node swelling |
constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes towa...
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constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes toward right breast and up to the right side on neck. pretty painful.
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| 44 | 2021-01-13 | lymph node swelling | Lymphadenopathy of right axillary lymph nodes. |
| 44 | 2021-01-13 | lymph node swelling |
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;...
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Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
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| 44 | 2021-01-13 | swelling, lymph node swelling | Swelling on left armpit and neck. |
| 44 | 2021-01-14 | lymph node pain, lymph node swelling |
Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the...
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Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the size of a quarter. It was very sore and painful to touch and movement. Pain scale 7/10. I treated it with warm compress infused with lavender oil, Ibuprofen 400 mg orally, self-massage, and rest. Symptoms lasted 24 hours. After 24 hours the lymph node was still swollen with dissipated soreness and pain. Pain scale 0-1/10.
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| 44 | 2021-01-14 | lymph node swelling | shot was in left upper arm- swollen lymph nodes under the arm being reported, last over 4 days |
| 44 | 2021-01-14 | lymph node swelling |
I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my ski...
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I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my skin). I developed left supraclavicular lymphadenopathy on 12/25 and that is still present and unchanged. I reported that prior. I developed a rash similar to pityriasis rosea on 1/11. This is progressive and still present. I do currently also have fatigue and possible conjunctivitis.
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| 44 | 2021-01-14 | lymph node swelling |
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o...
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Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
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| 44 | 2021-01-14 | swelling face |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-15 | lymph node swelling |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-17 | lymph node swelling | Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful. |
| 44 | 2021-01-18 | lymph node swelling |
Chills; Fever; Severe body aches; Lymphadenopathy; Exhaustion; This is a spontaneous report from a c...
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Chills; Fever; Severe body aches; Lymphadenopathy; Exhaustion; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via intramuscular route of administration on 06Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other product. Concomitant medications included escitalopram oxalate (LEXAPRO), alprazolam, and estazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 15:00, the patient experienced chills, fever, severe body aches, lymphadenopathy, and exhaustion. Treatment for the events included ibuprofen, Tylenol, sleep, and hot bath. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
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| 44 | 2021-01-18 | lymph node swelling |
moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left ...
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moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side; This is spontaneous report from a contactable nurse (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm), on 06Jan2021 at 15:45, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, no known allergies, and was not taking concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek5730) intramuscular in the right arm on 16Dec2020 at 18:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 05Jan2021, at 16:30, the patient experienced moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side. It was unknown if the patient received treatment for the events. Outcome of the events was not recovered.
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| 44 | 2021-01-19 | anaphylactic reaction | Systemic: Anaphylaxis, Systemic: Seizure-Severe |
| 44 | 2021-01-20 | swelling | Day 7 post vaccine developed hives and angioedema on face chin and forehead |
| 44 | 2021-01-21 | lymph node swelling, peripheral swelling |
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my...
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I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
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| 44 | 2021-01-21 | lymph node swelling |
Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fa...
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Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fatigue.
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| 44 | 2021-01-21 | swelling face |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-24 | lymph node swelling |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-24 | peripheral swelling, swelling face |
itching of all over body, started on arms and head the day following the vaccination. The second day...
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itching of all over body, started on arms and head the day following the vaccination. The second day following the vaccination I woke up with a swollen face and later on in the day my hands started swelling a lot. On the third day in my feet swell very little compared to my hands. I took benadryl which seemed to help. I have an appointment with my pcp tomorrow to get checked out. Today is day 5 and my hands are still swollen but the severity has lessened over the day today. I am very itchy all over my body.
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| 44 | 2021-01-25 | lymph node swelling, lymph node pain |
mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling ...
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mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received bnt162b2 (BNT162B2), the first dose (lot number: EH9899, expiry date: not reported), intramuscularly, on 18Dec2020 04:00 PM, at a single dose, on the left arm; and the second dose (lot number: EL1284, expiry date: not reported), intramuscularly, on 07Jan2021 11: 00 AM, at a single dose, on the right arm, both for COVID-19 immunization. The vaccine was administered in a hospital. The patient was not pregnant. Medical history included COVID. It was reported that patient was diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Concomitant medications included ethinylestradiol, levonorgestrel (JOLESSA), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VIT D); these are the other medications she received in two weeks. The patient did not receive any other vaccine within four weeks. The patient experienced mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes the evening following both covid 19 vaccine doses 1 and 2. This lasted 48-72 hours and then resolved. The first dose was received on 18Dec2020 with reaction occurred on 19Dec2020. The second dose was received on 07Jan2021 with reaction occurred on 08Jan2021 06:00 PM (also reported as "09Jan2021"). The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
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| 44 | 2021-01-26 | lymph node swelling |
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c...
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arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
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| 44 | 2021-01-26 | swelling |
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial...
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Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
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| 44 | 2021-01-27 | swollen extremities, swelling face | Edema in both hands and arms. Swollen face Lower lip swelling and tongue swelling |
| 44 | 2021-01-27 | swelling face |
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel...
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1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
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| 44 | 2021-01-27 | swelling face |
I had flu-like symptoms after the 2nd dose for 4 days. I got radiesse filler in my face 1/22/21 a...
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I had flu-like symptoms after the 2nd dose for 4 days. I got radiesse filler in my face 1/22/21 and about two days later developed facial swelling out of proportion to expected swelling
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| 44 | 2021-01-28 | swollen extremities |
Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swell...
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Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swelling that has not subsided after 24 hours.
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| 44 | 2021-01-28 | swelling face |
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi...
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My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
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| 44 | 2021-01-28 | swelling face |
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the thr...
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No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
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| 44 | 2021-01-30 | swelling | Fever, painful swelling redness and bruising since 5 hours after administering vaccine. |
| 44 | 2021-01-31 | lymph node swelling |
Approximately three hours after injection the lymph node in the armpit closest became swollen and ar...
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Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
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| 44 | 2021-01-31 | oral herpes |
She noticed a cold sore that occurred the day after she received the 2nd dose of vaccine. Treated wi...
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She noticed a cold sore that occurred the day after she received the 2nd dose of vaccine. Treated with Valtrex
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| 44 | 2021-02-02 | swollen extremities |
I had my 2nd dose of the Pizer vaccine on 1/30/2021 (Saturday at 4:20pm). The shot was given in my ...
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I had my 2nd dose of the Pizer vaccine on 1/30/2021 (Saturday at 4:20pm). The shot was given in my left arm. On 2/1/2021 Monday 10:00am) my left armpit was swollen and sore. You could visibly see the swelling. It was about the size of a lemon. I contacted my doctor who said the reaction was normal, but I wanted to report it because it was an adverse reaction. The swelling went down but is not gone, as of today, Wednesday 2/3/2021. I sent my doctor pictures as he is not seeing clients in person.
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| 44 | 2021-02-03 | lymph node swelling |
RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SY...
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RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SYMPTONS GOT WORSE NEXT DAY WITH INCREASED BODY ACHES,FEVER,SNEEZING, EAR PAIN,GLANDS SWOLLEN. TESTED FOR COVID 19 ON 01/26/2021. RESULTS WERE NEGATIVE AND WAS TOLD TO FOLLOW UP WITH PCP AND COULD NOT RETURN TO WORK TILL SYMPTONS IMPROVING. WENT TO PRIMARY DOCTOR AND WAS SWABBED FOR FLU,BACTERIAL.FUNGAL INFECTION. RESULTS CAME BACK AS BACTERIAL INFECTION AND AM NOW ON BACTRIM DS. STILL HAVING HEADACHE AND TIREDNESS.
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| 44 | 2021-02-03 | lymph node swelling |
enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 we...
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enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 weeks
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| 44 | 2021-02-04 | oral herpes |
1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the e...
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1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the evening with full recovery to baseline 1/31. 2/1 05:00 Upon waking, I noticed I could feel cold sores beginning on my lips. I occasionally experience A SINGLE cold sore after extreme exposure to elements, but not usually after illness. This morning I could feel MANY cold sore forming on my lips (top and bottom) as well as insides of my cheeks and gums. I can count at least 15 different sores that all came on simultaneously. Treating sores as usual with frankincense and balm to reduce cracking and bleeding. Sores taking usual clinical course, not healed yet.
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| 44 | 2021-02-04 | peripheral swelling |
was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Jo...
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was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose. She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown. Information about batch/lot number has been requested.
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| 44 | 2021-02-06 | lymph node swelling | Swollen lymph nodes |
| 44 | 2021-02-06 | peripheral swelling |
1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,...
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1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,diziness,syncope,Vital 120/82,82,96%. Given Benadryl 50mg po. 1419 Reports symptoms calming down less sensation of swelling and calming down. 1433 spoke with husband and notified of situation. 1515 Patient exited in stable condition. Agreed and understands of what to do if symptoms worsen or continue.
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| 44 | 2021-02-06 | peripheral swelling | Arm swollen, red and hot and very itchy. Developed rash all the way down to elbow. |
| 44 | 2021-02-07 | lymph node pain |
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w...
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Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
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| 44 | 2021-02-07 | peripheral swelling | Itching and swelling on hands and feet. |
| 44 | 2021-02-07 | peripheral swelling | Itching and swelling in hands and feet. |
| 44 | 2021-02-07 | swelling |
pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a sponta...
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pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a spontaneous report from a contactable Non-healthcare Professional. This Non-healthcare Professional reported that a 44-years-old female patient received bnt162b2 (BNT162B2; brand=Pfizer COVID; lot number=EL3302) second dose, via an unspecified route of administration at Left arm on 20Jan2021 11:30 AM at SINGLE DOSE for covid-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing, diagnosed with covid-19 prior to vaccination. No Allergies to medications, food, or other products. Historical vaccine included received first dose of Pfizer COVID 19 vaccine (lot number=EL3246) on 30Dec2020 at left arm for covid-19 immunization. Concomitant medication included budesonide and OTC vitamins. The patient experienced pain and swelling in arm pit of left arm on 22Jan2021 08:00 AM with outcome of recovering. No treatment received. The events reported as non-serious.The patient was not pregnant and not Pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19.
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| 44 | 2021-02-08 | anaphylactic reaction, swelling face |
Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was adminis...
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Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing
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| 44 | 2021-02-08 | axillary mass |
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle...
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Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
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| 44 | 2021-02-08 | lymph node swelling, lymph node pain |
Side effects of headache, bone pain, extreme fatigue, and lymph nodes in R axilla are swollen and so...
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Side effects of headache, bone pain, extreme fatigue, and lymph nodes in R axilla are swollen and sore. Treatment taking advil or Tylenol and rest. Received the vaccine on Friday 2/5/21 side effects lasted until Sunday 2/7/21 except lymphnode swelling and pain still present on 2/9/21
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| 44 | 2021-02-08 | lymph node swelling |
Pfizer-BioNTech Covid-19 Vaccine EUA 2/7/2021 @3am- fever which subsided at 11:30am, chills, body ac...
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Pfizer-BioNTech Covid-19 Vaccine EUA 2/7/2021 @3am- fever which subsided at 11:30am, chills, body aches, headache, fatigue lasting all day 2/8/2021- swollen lymph node left axilla, soft tissue swelling left axilla, no redness
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| 44 | 2021-02-08 | peripheral swelling |
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic ther...
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cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-09 | lymph node pain, lymph node swelling |
Vaccine on Friday; Saturday around noon lymph nodes got tender & swollen. Then on Sunday became larg...
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Vaccine on Friday; Saturday around noon lymph nodes got tender & swollen. Then on Sunday became large (size of eggs), painful. Located in : Left interior Arm, L armpit, hand, Left neck up to ear, breasts, Left wrist, Right hand. Monday at 10 a.m. went to doctor. Ran tests to make sure nothing else was underlying. Came back negative. Started on hydroxovisil to reduce swelling. 2/10/21 physician called to notify that lab results were all negative so they feel it is due to COVID-19 Vaccine.
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| 44 | 2021-02-09 | swelling face |
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b...
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fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
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| 44 | 2021-02-10 | lymph node swelling | headache, sore arm, and swollen node(s) in the armpit of the same arm |
| 44 | 2021-02-10 | lymph node swelling | Post-Vaccine Lymphadenopathy occurred 2 days after 2nd dose |
| 44 | 2021-02-11 | swelling |
Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl,...
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Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl, itchy to left hand, back head, and neck forty to fifty minutes. Take a dose of Benadryl around 8:00 pm . Itching lasted a week. Scratched the right lower leg and this created a raised bruise to that was sensitive to touch and lasted a week.
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| 44 | 2021-02-11 | swelling | Severe redness, rash, swelling, headache, nausea, muscle weakness and aches, joint pain, shakes |
| 44 | 2021-02-14 | lymph node swelling |
Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on righ...
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Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on right side and right side of neck in front.
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| 44 | 2021-02-14 | peripheral swelling |
Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of inject...
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Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
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| 44 | 2021-02-16 | lymph node pain, lymph node swelling |
low grade fever (100.4), chills, body aches, fatigue, swollen and painful lymph node under left armp...
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low grade fever (100.4), chills, body aches, fatigue, swollen and painful lymph node under left armpit
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| 44 | 2021-02-16 | swelling face |
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hou...
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within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
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| 44 | 2021-02-17 | lymph node swelling | left side of my neck, where my lymph note is, it is swollen |
| 44 | 2021-02-17 | lymph node swelling |
This is a spontaneous report received from a contactable other healthcare professional (who is also ...
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This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiry date unknown), intramuscular in the left arm, on 05Jan2021 17:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included asthma and high cholesterol. The patient has no allergy to medications, foot or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included atorvastatin (LIPITOR) and ethinylestradiol, norgestrel (CRYSELLE). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced upper left swollen lymph nodes (4) on 08Jan2021 13:30. The patient postponed 2nd shot until this is resolved. Ultrasound was done and was told biopsy was needed next. Therapeutic measures were taken as a result of upper left swollen lymph nodes (4) included ultrasound (as reported) on an unspecified date with unknown results. The event resulted to "doctor or other healthcare professional office/clinic visit". The outcome of the event was not resolved.
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| 44 | 2021-02-17 | lymph node swelling |
I am a travel RN and received the vaccine while working in TX. By 9 :00 am, I had a fever of 101 ...
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I am a travel RN and received the vaccine while working in TX. By 9 :00 am, I had a fever of 101 with body aches, chills, nausea, fatigue and abdominal cramps. By 11:00PM, my fever was 102.5 and I was in so much pain. I finally did take some medicine. About 24 hours after, the lymph nodes were swollen in my right arm pit. I couldn't turn my head because of the swollen lymph nodes in the right side of my neck.
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| 44 | 2021-02-21 | lymph node swelling |
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed...
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Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
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| 44 | 2021-02-21 | swelling face |
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ...
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1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
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| 44 | 2021-02-22 | swelling face |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
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| 44 | 2021-02-23 | lymph node swelling |
2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder an...
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2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder and arm, fever, fatigue, myalgias 2/24 low grade fever, otherwise same as 2/23
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| 44 | 2021-02-23 | lymph node swelling |
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati...
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Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
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| 44 | 2021-02-23 | lymph node swelling |
The morning after my injection, I woke up with swollen lymph nodes in my neck (on the left side) and...
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The morning after my injection, I woke up with swollen lymph nodes in my neck (on the left side) and at the base of my skull (in the back on the left side). I also had swollen tonsils. Additionally, the muscles in my shoulder, neck and head (on the left side- where I was given the injection) were tense and painful. It hurt to move them despite stretching them, massaging my shoulder and neck, applying ice to the areas to lower the swelling (for several hours), and ibuprophen. I am also fatigued, but I am told that this is a "normal" reaction to the vaccine. It is the second day and the swelling in my lymph nodes is less than yesterday, although they are still swollen, and the pain in my neck and shoulder is not as painful, but I still cannot turn my head quickly, and it is so stiff in the back of my neck that it hurts to lean my head back. I can lean my head back, but I have to take it very slowly, otherwise there is shooting pain.
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| 44 | 2021-02-25 | lymph node swelling |
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contac...
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Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 44 | 2021-02-28 | lymph node swelling |
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the...
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Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
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| 44 | 2021-02-28 | peripheral swelling, swelling |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | peripheral swelling | I woke up this morning with my hands swollen and bumpy with a red, rough rash. They do not itch. |
| 44 | 2021-02-28 | swelling face |
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell....
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One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
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| 44 | 2021-03-01 | lymph node swelling |
Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These s...
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Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These sx eventually improved. 72 hours latter diffuse macularpapular rash on trunk, inguinal region, back.
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| 44 | 2021-03-01 | lymph node swelling | Underarm and breast tenderness as well as swollen lymph nodes on the same side as vaccination |
| 44 | 2021-03-02 | anaphylactic reaction |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | swelling | Lower lip angioedema. Patient has history of angioedema caused by ACE inhibitor and lip fillers also |
| 44 | 2021-03-02 | swelling face |
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side...
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2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
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| 44 | 2021-03-02 | swelling |
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation...
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Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
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| 44 | 2021-03-04 | oral herpes |
I have a history of fever blisters and have infrequent flare ups during or after illness or in time...
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I have a history of fever blisters and have infrequent flare ups during or after illness or in times of stress or too much sun. I got a fever blister on my lip on Friday following my vaccine the Tues before. Not sure if they are connected but wanted to report.
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| 44 | 2021-03-07 | lymph node swelling |
After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I...
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After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.
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| 44 | 2021-03-07 | lymph node swelling |
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender...
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Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
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| 44 | 2021-03-08 | lymph node swelling | Swollen lymph nodes on left side of neck and terrible sore throat only on the left side as well. |
| 44 | 2021-03-08 | swollen extremities |
1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea ...
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1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea has continued daily, vomiting is decreased to 2-3 days/week. Zofran 8mg has been used as needed 2/8/21 ALT164, AST 156 (increased from post vaccine January '21) Aldolase 10.2, CK 199, Alk Phos and Bilirubin normal, WBC and neutrophil sudden decrease. UA 4+ bacteria epith cells and protein... worsening but negative culture 1/2021palpitations and chest pain intermittent but no respiratory distress Other Items: petechial rash to lower flank and extremities, facial rash, peripepheral edema, rash, and pain consistent with vascular inflammation. Right temporal lobe painful to touch. Neck pain. Throat pain and difficulty swallowing
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| 44 | 2021-03-09 | lymph node pain, lymph node swelling |
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injection...
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lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-11 | lymph node swelling |
Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 ...
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Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 inch increase in chest circumference). Pain and tenderness.
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| 44 | 2021-03-12 | anaphylactic reaction |
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen...
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Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
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| 44 | 2021-03-12 | swelling |
SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene ...
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SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene transferred to Emergency room via ambulance C/) SOB, itching and swelling at the back of her throat and in her neck. No hives. No syncope. Described as moderate and later mild. No radiation, no vomiting, no wheezing. Patient discharged from ED at 09:30 am
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| 44 | 2021-03-13 | swelling face |
Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and t...
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Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and throat as symptoms progressed.
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| 44 | 2021-03-14 | lymph node swelling |
Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches wi...
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Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches with no fever 24 hours after vaccination lasting 12 hours; Chills; Swollen lymph node in armpit of vaccinated arm 48 hours after vaccination.; Vivid nightmares 14 hours after vaccination.; This is a spontaneous report from a non-contactable other healthcare professional (patient). A non-pregnant 44-years-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3247, via an unspecified route of administration on 06Feb2021 09:45 (at the age of 44 years old) at SINGLE DOSE in the left arm for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies.Historical vaccine information included BNT162B2, Lot EL9269, on 16Jan2021 10:00 AM in the Left arm, Dose number 1. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 21:00, the patient experienced chills and aches with no fever 12 hours after the vaccination, sleeplessness throughout the night. The chills and aches with no fever 24 hours after vaccination lasting 12 hours. Patient experienced vivid nightmares 14 hours on unspecified date in Feb2021 after vaccination. Patient experienced swollen lymph node in armpit of vaccinated arm 48 hours on unspecified date in Feb2021 after vaccination. No treatment was received for the events. Outcome of the vivid nightmares, Ache , Sleeplessness throughout the night, chills, Swollen lymph node in armpit was recovered in Feb2021. No follow up attempts are possible. No further information is expected.
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| 44 | 2021-03-15 | lymph node swelling, lymph node pain |
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme so...
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After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been peeling extremely bad
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| 44 | 2021-03-15 | lymph node swelling, oral herpes |
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel ...
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lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-03-15 | swelling | Swollen shoulder and pain. Swollen eyes and face. |
| 44 | 2021-03-15 | swelling |
Large swollen lump in groin area (left leg), irritated during day from sitting and was pussing white...
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Large swollen lump in groin area (left leg), irritated during day from sitting and was pussing white liquid at night for about a week.
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| 44 | 2021-03-17 | lymph node swelling | Swollen lymph node and pain in left armpit |
| 44 | 2021-03-17 | swelling face |
every where she had had filler injections are swollen except the left eye, her left eye is not swoll...
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every where she had had filler injections are swollen except the left eye, her left eye is not swollen; every where she had had filler injections are swollen except the left eye/her doctor believes she is having a reaction with her fillers/bump on her right eye; under her right eye there was a large bump that was swollen; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration in the left upper arm, on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included Hashimoto's disease from 2017 and ongoing, cosmetic filler injections got in her face within the last year and half or 2 years. Patient said that she knew that Allergan asked her doctor about her ongoing Hashimoto's as well. She takes medication for that. Patient also said that her white blood cell count runs low, like around 2 if they want to note that as an immune system thing and she confirmed that was an issue for her prior to receiving the COVID 19 vaccine. Family medical history included that her daughter has Hasimotos as well. Concomitant medications included unspecified medications for Hashimoto's disease. The patient previously received first dose of BNT162B2 (lot number: EI1685) via an unspecified route of administration in the left upper arm on 18Dec2020 at the year of 44 years at single dose for covid-19 immunisation. She said her doctor believes she is having a reaction with her fillers. She clarified fillers were like cosmetic injections got in her face. She thought the filler was called Allergan but she didn't have any other information about it. She did know her doctor did call Allergan and did a report with them. She thought it was like a big deal because it was not documented with Pfizer just with Moderna. She said the doctor was also going to call and report this as well. The doctor has not called yet but he said he was going to, she just left their office. Basically the places she had had filler injections within the last year and half or 2 years not have, under her right eye there was a large bump that was swollen and then the places that were called labial folds, the marionette lines where she had had filler there were all swollen and that was on the right side of her face and then on the left side the marionette lines were swollen as well so basically everywhere she had had filler injections were swollen except the left eye, the left eye is not swollen. And the places were swollen and hard. She first noticed the swelling yesterday 25Jan2021. The bump on her right eye was yesterday around 15:00 and then this morning (26Jan2021) it was much worse under her eye and she noticed the bumps on the right side at about 6 am this morning and around 9 am she began feeling it on the left side and it progressively has gotten worse since it started in all of those areas (26Jan2021). This case reported as serious. Patient did not visit Emergency Room, but she has been to 2 different physicians in physician office. No other vaccines administered on the same day as either dose of the suspect product. Patient did not have prior vaccinations within 4 weeks. Outcome of the events was not recovered. Reporter assessed event everywhere she had had filler injections are swollen except the left eye, her left eye is not swollen as related to BNT162B2.; Sender's Comments: Based on available information a contributory role of BNT162B2 to reported events cannot be fully excluded. Consideration should also be given to the contribution from the cosmetic filler injections. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-03-20 | lymph node swelling |
Swollen Lymph nodes under left Armpit ongoing Extreme Fatigue ongoing Low grade fever for 1 day Body...
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Swollen Lymph nodes under left Armpit ongoing Extreme Fatigue ongoing Low grade fever for 1 day Body aches and chills for 1 day
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| 44 | 2021-03-21 | lymph node pain, lymph node swelling |
Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in...
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Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in left arm) and by mid-afternoon headache. Overnight woke with fever, chills, headache and sore arm making sleep impossible. Ill all day Friday - fever, chills, fatigue, no appetite, headache, arm soreness. Friday evening awoke with intense pain in right arm pit, breast, upper ribs - extremely swollen lymph nodes (size of avocado). Extremely tender and sore. Pain continued throughout Saturday, Sunday, and now into Monday. Also still fatigued and feeling run down.
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| 44 | 2021-03-21 | swelling, peripheral swelling |
Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc mar...
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Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc marks developed as well where swelling was, armpits, shoulder blade and legs all right side. Swelling increased became very red and hot to touch, itching all where marks were. I was taking Benadryl and applying cortisone cream. On Friday went to walk in, advised not much they can do stop taking Benadryl. On 0321.2021 hives broke out all on right arm started Benadryl again. Still have them now over a week later.
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| 44 | 2021-03-25 | anaphylactic reaction | Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm |
| 44 | 2021-03-26 | anaphylactic reaction |
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra...
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Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
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| 44 | 2021-03-26 | lymph node swelling |
Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep ...
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Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep rest of night/early morning. Developed all over body aches, chills subsided by noon on same day they began. Injection site swelled, and was very red. Swelling spread to underarm/lymph node area. Headache began in early morning on day after shot as well, and nausea set in as well. Slept most of day, ran fever, was nauseous, and achy. The second day after the vaccine was improved - no headache, appetite returned, fever was better. Arm and underarm was still red, swollen and sore, and had overall tiredness and still achy. The only lasting side effect was the red, swollen, and sore arm, which is now almost back to normal. There is still some soreness in the arm and underarm, but the redness and swelling is gone as of 3/22.
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| 44 | 2021-03-26 | swelling face |
My arm became very hot later in the night and then my face got really hot and when I woke up my face...
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My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
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| 44 | 2021-03-26 | white blood cell count increased |
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel...
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She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
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| 44 | 2021-03-28 | lymph node swelling | Patient?s left: Dorsal shoulder pain , inflammation of lymph nodes. |
| 44 | 2021-03-29 | lymph node swelling |
body aches, headache, and swollen axillary lymph nodes 44 year old female (DOB: 11/08/1976) receive...
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body aches, headache, and swollen axillary lymph nodes 44 year old female (DOB: 11/08/1976) received the 2nd dose of the Pfizer COVID-19 vaccine at Track on 03/26/2021 @ 13:30. Pt started experiencing body aches, headache, and swollen axillary lymph nodes on 03/26/2021 @ 21:00. Pt takes Diltiazem 120mg and Omega-3 supplement. Pt has microvascular dysfunction cornary vasospasm. Pt is allergic to Percocet, does not remember whether doctor specified the allergy was to oxycodone/opioid. Pt has not taken opioids since percocet reaction. Pt has taken Tylenol several times since percocet reaction, and has not experienced any side-effects or allergic type reactions. Pt prefers IBU because of the longer lasting effects. Allergy was likely related to opioid/oxycodone. Pt was advised to take Tylenol, monitor axillary lymph nodes, and if headache worsens, axillary lymph nodes swelling increases, or symptoms do not alleviate in 2 days to contact primary doctor for medical care. was consulted and Dr. was notified.
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| 44 | 2021-03-30 | anaphylactic reaction |
20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used i...
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20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used inhaler twice with no relief, was taken from coliseum by ambulance to ER. Enroute given epinephrine and 50 ml of benadryl. At ER repeat epinephrine and benadryl, H1/H2 blockers given. Released after three hour observation. Diagnosis of anaphylaxis.
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| 44 | 2021-03-30 | anaphylactic reaction |
Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assist...
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Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assistant). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration in left arm on 12Mar2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism, bipolar and high blood pressure. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown if patient had covid prior vaccination. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN). On 12Mar2021 at 18:45, the patient experienced anaphylaxis. It was reported that patient visited emergency room/department or urgent care. The patient took Benadryl and 2 epinephrine shots as a treatment. It was reported that COVID test was not done after post vaccination. The outcome of the event was resolved on Mar2021.
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| 44 | 2021-03-30 | lymph node swelling |
bumps on lymph node; This is a spontaneous report received from a contactable consumer (patient). A ...
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bumps on lymph node; This is a spontaneous report received from a contactable consumer (patient). A 44 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) first dose on 03Mar2021 via an unspecified route of administration as single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. Patient stated that she was due to receive second dose but was reporting bumps on lymph node on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 44 | 2021-04-01 | anaphylactic reaction |
Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB)...
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Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB) after running outside around a lake. No previous history of anaphylaxis or allergies. Reports that she had her COVID-19 vaccine 1 week ago. and had question about if that could have contributed to the event.
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| 44 | 2021-04-01 | swelling face |
Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded ...
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Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded to Benedryl and Claritin. Headache continues off and on for 2 weeks.
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| 44 | 2021-04-02 | swelling face |
On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about ...
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On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about 7:30 pm, I started feeling bruising under my right eye. At about 9:30 pm, I had a small bump under my left eye. On 4/3/21, I woke up with facial swelling. I was swollen underneath my eyes, cheeks were swollen, and lip was swollen. Headache, slight back ache, redness at injection site and sore injection area continue. Took 2 Benadryl at 9:00 am to reduce swelling.
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| 44 | 2021-04-02 | white blood cell count increased |
Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Th...
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Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Thursday morning and has continued since then. Friday night I experienced a loud pop on the left side of my head - pressure released on the left year slightly followed by numbness and tingling in face along with blurred vision, dizziness and weakness in left leg. Blurred Vision lasted maybe 1-2 minutes, numbness and weakness/dizziness resolved on ride to ER so maybe 10 minutes as we live near the hospital. ER evaluated me for potential stroke. Cat scan and labs done. Nothing odd was noted. Doc decided it was parethesia of left leg and nonintractable episodic headache event. Blood pressure was elevated which is unusual for me along with a high White blood cell count- Doc said this is normal with just having received a vaccine recently. No concerns with platelets or enzymes and electrolytes. Doc does think it could be vaccine related as that is the only thing new this week. Due to earlier in the week side effects, my PCM did COVID test me just incase since the side effects were hanging around longer than the normal window of time and nasal swab PCR came back negative.
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| 44 | 2021-04-03 | lymph node swelling, lymph node pain |
At the 36 hour mark clavicle lymph node swelled to a gum ball size, palpable and extremely painful. ...
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At the 36 hour mark clavicle lymph node swelled to a gum ball size, palpable and extremely painful. As of this claim, still large and pain had reduced by 25%
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| 44 | 2021-04-03 | swelling | Painful swelling in left armpit. Fatigue. Headache. |
| 44 | 2021-04-17 | anaphylactic reaction |
Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; It...
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Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 (Batch/Lot Number: Ep-7534) as single dose for COVID-19 immunization. Medical history included seasonal allergy, asthma, and known allergies: penicillin. Concomitant medication included fexofenadine hydrochloride (ALLEGRA); montelukast sodium (SINGULAIR); amlodipine. all taken for an unspecified indication, start and stop date were not reported. The patient previously took grastek for immunomodulatory therapy and experienced drug allergy; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En-6198) on 27Feb2021 for COVID-19 immunization. On unspecified date the patient experienced itching all over, coughing, asthma, anaphylaxis. The patient received 2 doses of epinephrine, 100 ml benedryl, and h1h2 bloc. The outcome of the events was recovering. The patient was not tested post vaccination and did not has COVID prior to vaccination.
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| 44 | 2021-04-20 | swelling |
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int...
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Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-04-26 | lymph node swelling |
The day after the vaccine I was in a lot of pain. It started overnight my Lymph nodes were very swol...
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The day after the vaccine I was in a lot of pain. It started overnight my Lymph nodes were very swollen and my neck was stiff. As the day went on I started to get more bumps on my head and other places. The bumps were severely painful and I could barely move my head without flinching. I went to the ER and the doctor said it was a normal reaction with my Lymph Nodes. I actually had the Shingles and had to return to the ER again. The second time at the the ER it was identified immediately. The rash was mostly on my head with a few on my torso which cleared up sooner. It has been 31 days and I still have episodes of severe pain once or or twice daily and don't last as long. The pain is a level 10 when it is severe. It is at a level five when it is not spiking. I have not had any problems with my pregnancy so far and I am twenty eight weeks. Due Date 07/17/2021 Pregnancy-second pregnancy
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| 44 | 2021-04-27 | lymph node pain, lymph node swelling | Swollen and painful lymph nodes and left under arm |
| 44 | 2021-04-27 | lymph node swelling | Extremely swollen armpit lymph node, very tender. Tiredness, body muscle aches, headache |
| 44 | 2021-04-27 | lymph node swelling |
1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued...
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1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued and I went to Dr. on 4/06/2021. Dr. treated me with Toradol and Tylenol#3. Schedule me to have a mammogram and ultrasound on 4/20/2021. This is when it was discovered I had a clot in left arm. Currently being treated with blood thinners(Eliquis).
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| 44 | 2021-04-29 | lymph node swelling |
Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness t...
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Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness tiredness. On Monday afternoon noticed lymph node in front of right ear opposite side of vaccine was swollen on Tuesday notice that there was fluid swelling directly under my right knee went to the doctor they said to monitor symptoms Thursday woke up to swelling in face on the left side between nose and cheek. Today feeling tinglingness in both legs hands and swelling continues in face right lymph node in front of ear is not as large.
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| 44 | 2021-05-03 | peripheral swelling |
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d...
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Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
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| 44 | 2021-05-04 | anaphylactic reaction |
Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an A...
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Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced
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| 44 | 2021-05-04 | swelling face |
Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is ...
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Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 15Feb2021 at 09:15 (at the age of 44-year-old) as a single dose for Covid-19 immunization in Hospital. The patient had known allergies: sulfa, penicillin, latex. The patient did not had any other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included melatonin, magnesium, cetirizine hydrochloride (ZYRTEC), and azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 25Jan2021 at 08:15 as a single dose for Covid-19 immunization. On 20Feb2021 at 7:30, the patient experienced rash and hives on face, throat itchiness, and swollen face around eyes. Patient received treatment with Oratidine, Benadryl, and Prednisone for the events. The outcome of the events of rash and hives on face, throat itchiness, and swollen face around eyes was recovering. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-05-10 | lymph node swelling |
pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules ...
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pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-05-11 | lymph node swelling, lymph node pain | Monday, May 3 developed lymph node on left collar bone, went to ER due to pain on Thurs May 6 |
| 44 | 2021-05-11 | oral herpes, lymph node swelling |
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and...
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blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
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| 44 | 2021-05-14 | anaphylactic reaction |
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right...
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blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
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| 45 | 2020-12-31 | anaphylactic reaction |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2020-12-31 | peripheral swelling |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2021-01-03 | lymph node pain |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-04 | peripheral swelling |
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ...
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Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
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| 45 | 2021-01-04 | swelling |
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou...
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Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
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| 45 | 2021-01-05 | lymph node swelling | Significant left subclavicular lymphadenopathy; single area measured 10 mm on ultrasound. |
| 45 | 2021-01-06 | lymph node pain |
Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to l...
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Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to lymph nodes under left axilla and neck
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| 45 | 2021-01-06 | lymph node swelling, peripheral swelling |
Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at sit...
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Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at site. Applied ice and heat. States it is getting better but if "ball" does not get any better would like to be seen. Agreed with aptient
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| 45 | 2021-01-06 | peripheral swelling, lymph node swelling | patient called stating she had swelling of arm with lymph nodes. |
| 45 | 2021-01-07 | lymph node swelling |
On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to...
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On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to my neck, left arm and under the arm and clavicle. My lymph nodes are swelling and I am concerned since I never had my lymph nodes swell up. On my second injection 01-06-2021, I continue with lymph node swelling and my symptoms do not seem to go away. I went to see my doctor, that said it was probably a reaction to the Pfizer injection and he is recommending that in February 2021, if I still have swelling to my lymph nodes then lab work will be performed.
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| 45 | 2021-01-07 | swelling face |
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a...
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Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-08 | lymph node swelling, lymph node pain |
Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. H...
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Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. Headache, chills, sore thrat, nasal congestion started mostly day after, headache day of both tbe first and second vaccine
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| 45 | 2021-01-10 | peripheral swelling |
Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swel...
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Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swelling and itching continued to get worse. Site was hot. Stared taking Zyrtec twice a day. Within 48 hours site was so swollen visible through clothes, like a plum under the skin and was hot, itching. 99.5 temp Added Pepcid on Sunday, Swelling started going down, better Monday morning.
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| 45 | 2021-01-10 | peripheral swelling |
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an...
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Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
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| 45 | 2021-01-10 | swelling |
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv...
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Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
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| 45 | 2021-01-11 | peripheral swelling, lymph node pain, lymph node swelling |
Received second dose of COVID vaccine on 1/6/21. On 1/9/21, expericenced left axillary swollen lymph...
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Received second dose of COVID vaccine on 1/6/21. On 1/9/21, expericenced left axillary swollen lymph nodes/ tenderness to left axillary region. Received vaccine in left arm. Spoke with employee via Employee Phone hotline and was instructed to fill out safe watch report. Employee took Ibuprofen for discomfort and performed massage to lymph area. Left arm and axillary area swollen on 1/12/21 during EH visit.
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| 45 | 2021-01-12 | swelling |
23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurren...
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23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurrence of angioedema in lips. A 3rd occurrence took place 1/12/2021 and this occurrence was most severe of the 3 occurrences so far.
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| 45 | 2021-01-12 | lymph node pain, lymph node swelling | Sore lymph nodes underarm left arm Very sore and swollen lymph nodes above the left collarbone |
| 45 | 2021-01-12 | lymph node swelling, lymph node pain |
on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore wi...
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on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore with head movement to the left.
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| 45 | 2021-01-12 | swelling | Rash all over body with swelling and blisters |
| 45 | 2021-01-12 | swelling |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-13 | lymph node swelling |
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nau...
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On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness, fever-100.7, muscle ache, swollen gland still
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| 45 | 2021-01-13 | swelling face |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | lymph node swelling |
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve...
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Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
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| 45 | 2021-01-14 | lymph node swelling |
On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The followi...
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On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The following day I woke up with my axillary lymph nodes swollen and extremely painful. I addition I did have headache and fatigue. 90% of swelling has decreased on post day 3. Today at this time I am still having altered sensation and discomfort in left arm.
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| 45 | 2021-01-14 | lymph node swelling | swollen lymph nodes in arm pits and neck area, extreme fatigue |
| 45 | 2021-01-14 | peripheral swelling |
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared ...
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Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
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| 45 | 2021-01-17 | anaphylactic reaction |
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment...
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Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
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| 45 | 2021-01-17 | lymph node swelling, axillary mass |
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai...
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nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
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| 45 | 2021-01-17 | lymph node swelling |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-18 | lymph node swelling, axillary mass |
Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painf...
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Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painful and still there.
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| 45 | 2021-01-18 | lymph node swelling, lymph node pain |
left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tender...
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left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tenderness; This is a spontaneous report from a contactable nurse. A 45-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 16Dec2020 11:15 to 16Dec2020 11:15 at a single dose for covid-19 immunization. Medical history included seasonal allergy and Sulfa drugs Allergies. Concomitant medication included minerals nos, vitamins nos (CENTRUM A to Z) and naproxen sodium (ALEVE). The patient had left subscapular lymph node swelling with tenderness on 01Jan2021. The outcome of the events was recovering.
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| 45 | 2021-01-18 | peripheral swelling |
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,...
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Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
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| 45 | 2021-01-18 | peripheral swelling |
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ...
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Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
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| 45 | 2021-01-19 | lymph node swelling |
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (...
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1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
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| 45 | 2021-01-19 | swelling face | Swelling of face and pain with stiffness of neck muscles |
| 45 | 2021-01-20 | lymph node swelling, lymph node pain |
Lymph node in right arm pit extremely swollen and painful for 2 full days. Still slightly swollen at...
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Lymph node in right arm pit extremely swollen and painful for 2 full days. Still slightly swollen at day 3.
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| 45 | 2021-01-20 | lymph node swelling |
chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable heal...
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chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable healthcare professional (patient). This 45-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot 9231) intramuscular, in left arm, on 30Dec2020 at 17:45, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included allergy to sulfamethoxazole (BACTRIM). The patient had no COVID19 prior vaccination and was not tested after vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE) 0.15-0.03 (unspecified unit and frequency). On 02Jan2021 the patient experienced chest and axillary adenopathy and tender clavicular. No treatment was given. The events had not yet resolved at the time of report.
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| 45 | 2021-01-20 | lymph node swelling | Cough, asthma, headache, fatigue, fevers, muscle and joint pain, nausea, chills, swollen lymph node |
| 45 | 2021-01-21 | lymph node pain |
severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the le...
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severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the left arm where the injection was received.
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| 45 | 2021-01-21 | lymph node swelling, peripheral swelling |
Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R ar...
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Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R armpit
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| 45 | 2021-01-21 | lymph node swelling |
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio...
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Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
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| 45 | 2021-01-23 | swelling face |
My right arm broke out in hives a few hours following the injection, and then my left arm a few hour...
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My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.
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| 45 | 2021-01-23 | white blood cell count increased |
Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White an...
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Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White and red blood cells elevated. Dx with reaction to vaccination.
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| 45 | 2021-01-24 | lymph node swelling, lymph node swelling, peripheral swelling |
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod...
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She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
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| 45 | 2021-01-24 | swelling face, swelling |
Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eye...
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Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling
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| 45 | 2021-01-24 | swelling, lymph node swelling |
office pocus revealed a 2.5 cm lymph node; 36 hours after second shot I developed marked swelling an...
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office pocus revealed a 2.5 cm lymph node; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; This is a spontaneous report from a contactable physician reported for herself. This 45-year-old female patient started the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL1284), via an unspecified route of administration at single dose on 09Jan2021 14:30 for covid-19 immunisation. Medical history included anxiety. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), escitalopram oxalate (LEXAPRO). Previously the patient received the first dose of BNT162B2 (Lot # EK5730), in the left arm on 19Dec2020 02:15 PM for covid-19 immunisation. On 11Jan2021 02:30, the patient experienced that office POCUS revealed a 2.5 cm lymph node, 36 hours after second shot I developed marked swelling and pain in my left axilla. Swelling persists into day 3. The outcome of the events was recovering. The patient underwent lab tests and procedures which included ultrasound scan: 2.5 cm lymph node on 11Jan2021 (Office POCUS revealed a 2.5 cm lymph node). Therapeutic measures were taken as a result of the events included Naproxen. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.
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| 45 | 2021-01-24 | swelling, swelling face |
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she...
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Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
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| 45 | 2021-01-26 | lymph node pain, lymph node swelling |
On 1/17 awoke with sore neck and swollen and tender lymph nodes in left neck/shoulder/arm. Evaluated...
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On 1/17 awoke with sore neck and swollen and tender lymph nodes in left neck/shoulder/arm. Evaluated at hospital occupational health and received a prescription for steroids.
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| 45 | 2021-01-26 | lymph node swelling |
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on ...
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lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | lymph node swelling | Extreme headache, 101 temp. Reactive lymphadenopathy at clavicle on side of injection. |
| 45 | 2021-01-27 | lymph node swelling |
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad...
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5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
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| 45 | 2021-01-27 | swelling face |
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ...
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1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
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| 45 | 2021-01-27 | swelling face |
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive...
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Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
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| 45 | 2021-01-29 | peripheral swelling | Swelling and soreness pain under left armpit front lower |
| 45 | 2021-01-31 | lymph node swelling |
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol...
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Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
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| 45 | 2021-01-31 | peripheral swelling, swelling |
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an...
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nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
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| 45 | 2021-01-31 | peripheral swelling |
Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev...
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Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.
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| 45 | 2021-02-01 | swollen extremities, lymph node swelling |
1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACH...
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1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACHES, HEADACHE AND SWOLLEN AXILLARY NODES IN LEFT ARM LASTING ABOUT 24-36 HOURS. 4 200ML ADVIL TAKEN SWOLLEN NODES REMAINED SUNDAY MORNING AND I WOKE WITH LEFT SIDE OF MY FACE NUMB BUT FUNCTIONING WHICH CONTINUED FOR ABOUT 48 HOURS. TODAY (2/2/21) IS DAY 5 POST INJECTION, SWOLLEN NODES REMAIN AND PINS AND NEEDLES FEELING ON LEFT SIDE OF FACE
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| 45 | 2021-02-02 | lymph node swelling | Injection Site Pain, Congestion, Fatigue, Swollen Lymph nodes, Nausea, & Headache |
| 45 | 2021-02-02 | lymph node swelling | Swollen lymph node 1 week after vaccine |
| 45 | 2021-02-02 | peripheral swelling | Extreme swelling, redness, and soreness in left arm, can barely lift. |
| 45 | 2021-02-02 | swelling face |
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute...
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Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
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| 45 | 2021-02-03 | lymph node pain, lymph node swelling |
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 2...
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Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
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| 45 | 2021-02-03 | lymph node swelling |
lymph node swelling; This is a spontaneous report from a contactable other healthcare professional (...
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lymph node swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ek9231, expiry date unknown), intramuscular at the right arm on 05Jan2021, 15:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included atenolol and ibuprofen (MOTRIN). The patient previously received first dose of BNT162B2 for COVID-19 immunization on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Patient was not pregnant at the time of vaccination. The patient experienced lymph node swelling on 07Jan2021. The event resulted to physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. The outcome of the event was recovered on Jan2021. The event was non-serious.
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| 45 | 2021-02-05 | lymph node swelling | Left axilla pain, feeling of left axilla swelling Fever General malaise |
| 45 | 2021-02-05 | lymph node swelling | L arm pain. L sided lymphadenopathy anterior cervical, supraclavicular |
| 45 | 2021-02-07 | lymph node pain, lymph node swelling |
fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near le...
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fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
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| 45 | 2021-02-07 | lymph node swelling |
Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following inj...
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Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following injection was 99.8); Significant lethargy; "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176), via an unspecified route of administration in the left arm on 20Jan2021 at 07:00 at a single dose in the hospital for covid-19 immunization. Medical history included hyperlipidaemia, depressive disorder, chronic anxiety disorder, hypertensive, allergies to PCN (anaphylactic) and sulfa (allergic). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), escitalopram oxalate (LEXAPRO), losartan, and Mg/Ca supplement. The patient experienced swollen axillary lymph on left arm, "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours, low grade fever (daily average: 97.3. For 24 hours following injection was 99.8), and significant lethargy on an unspecified date. The patient did not receive treatment for the events. Outcome of the event headache was recovered and for other events was reported as recovering.
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| 45 | 2021-02-07 | lymph node swelling |
Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swoll...
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Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
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| 45 | 2021-02-07 | lymph node swelling |
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac...
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Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
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| 45 | 2021-02-07 | peripheral swelling | COVID Arm - raised patch 3 inches in diameter |
| 45 | 2021-02-07 | swelling face |
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr...
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swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
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| 45 | 2021-02-07 | swelling |
Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a ...
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Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
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| 45 | 2021-02-09 | lymph node swelling |
Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactab...
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Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek9231) via intramuscular in left arm on 02Jan2021 18:00 at single dose for COVID 19 immunization. The patient received the vaccine in hospital. Medical history included asthma, migraine. Known allergies included Latex allergy. Concomitant medication included oral contraceptive pill (OCP), ergocalciferol (VIT D), melatonin, ubidecarenone (COQ10) and fexofenadine hydrochloride (ALLEGRA). No other vaccine was received in four weeks. The patient didn't have COVID prior vaccination. The patient experienced headache, brain fog, myalgia, chills, lymphadenopathy on 03Jan2021. Therapeutic measures were taken as a result of events including ibuprofen (MOTRIN). The events did not require Emergency Room Visit or Physician Office Visit. No COVID was test post vaccination. The outcome of events was recovered in Jan2021.
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| 45 | 2021-02-09 | lymph node swelling |
Severe swollen lymph node left axilla/ Injection site left arm; This is a spontaneous report from a ...
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Severe swollen lymph node left axilla/ Injection site left arm; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9262), via an unspecified route of administration on 22Jan2021 13:00 at a single dose on left arm for COVID-19 immunization. Medical history included Hypothyroidism, depression, vit D def., penicillin allergy and COVID-19. Concomitant medication included liothyronine sodium (CYTOMEL), levothyroxine sodium (SYNTHROID), celecoxib (CELEXA [CELECOXIB]), omega-3-acid ethyl ester (LOVAZA), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and an unspecified vitamin. The patient experienced Severe swollen lymph node left axilla/ Injection site left arm on 22Jan2021 18:00. No treatment received for the event. The outcome of the event was recovering. The patient was not pregnant. No other vaccine in four weeks. Not COVID tested post vaccination.
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| 45 | 2021-02-09 | lymph node swelling | Swollen lymph node |
| 45 | 2021-02-09 | swelling |
I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed ...
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I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed 2/3/21, I awoke with hives on my neck and chest, I took a Clarinex. The hives progressed t/o the day. I took a Benadryl that evening. I had difficulty sleeping d/t the burning and itching. I took another Benadryl at 0130 on 2/4/21. By 0930 on 2/4/21 my entire torso and scalp was inflamed. My shoulders were swollen. I had difficulty swallowing. I had a sudden "brain fog" with difficulty speaking and a major headache. I took another Benadryl. I then slept for 21 hours with a half hour awake period for lunch and scheduled Benadryl every 6 hours. My PCP recommended Pepcid 20 mg po BID x 5 days so I started that as well, and I took tylenol for the headache. The next day my rash had improved. I was tired but not extremely fatigued like the day prior. I gradually felt better t/o the day. Saturday 2/6/21, I awoke with resolution of all s/s.
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| 45 | 2021-02-10 | c-reactive protein increased |
Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficul...
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Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficulty getting up from a sitting position. Missed work on week 3. Worsened each week until that point. Improves with rest but worse after on feet more. Extreme exhaustion. Some chest pressure started on week 2
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| 45 | 2021-02-10 | lymph node swelling, lymph node pain |
Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left...
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Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left axilla. In am on 2/10/21 she could not move left arm due to swelling and pain in lymph nodes. Woke up 2/11/21 and still couldn't move arm due to discomfort. Also developed a runny nose, slight upper abdominal pain, and slight headache.
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| 45 | 2021-02-10 | swelling face |
Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; ras...
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Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; rash on neck and upper chest area; This is a spontaneous report from a contactable consumer (patient) This 45-years old no pregnant female consumer received the firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 on 21Jan2021 04:45 at left arm at single dose for Covid-19 immunization. Medical history included:allergies to medications, food or other products and high blood pressure .The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered:Other.On 21Jan2021 17:00 the patient developed Tingling of tongue and lips, Swelling of cheeks, face turned flush, rash on neck and upper chest area.The patient was treated with Benadryl. Events was reported as non serious .Outcome of the events was recovering. No Prior to vaccination, was the patient diagnosed with COVID-19. No Since the vaccination, has the patient been tested for COVID-19.
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| 45 | 2021-02-11 | peripheral swelling |
Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typical...
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Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typically flat, but is raised as a result of inflammation
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| 45 | 2021-02-15 | lymph node swelling | Swollen lymph nodes under arms |
| 45 | 2021-02-15 | lymph node swelling |
I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as c...
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I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as cellulitis. I am on a 10 day course of antibiotics. My left arm, where the dose was given, is red, slightly swollen, and sore to the touch. My doctor has advised to continue to take ibuprofen and to treat with ice packs. I would expect it to resolve in ten days when the antibiotics are completed.
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| 45 | 2021-02-18 | lymph node swelling |
Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, ace...
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Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, acetametaphine, and 14 days of doxycycline
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| 45 | 2021-02-18 | lymph node swelling |
Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm)...
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Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm), loss of appetite, rash
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| 45 | 2021-02-19 | anaphylactic reaction |
While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chew...
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While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.
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| 45 | 2021-02-21 | swollen extremities, lymph node swelling |
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da...
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Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
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| 45 | 2021-02-24 | swelling |
Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 w...
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Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 weeks following second dose of vaccine. Employee has officially reported symptoms. Referred employee for COVID testing.
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| 45 | 2021-02-25 | lymph node pain, lymph node swelling |
I experienced a swollen lymph node after the first shot on 1/12/2021. It went away within a week. Af...
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I experienced a swollen lymph node after the first shot on 1/12/2021. It went away within a week. After the second dose 2/2/2021 the same lymph node (left side above my collar bone , became inflamed again. It never went away but decreased in size after about 10 days. ON 2/21/the lymph node increased in size , it is the size of a grape and is very painful. I am also fatigued an have a general feeling of being unwell.
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| 45 | 2021-02-25 | lymph node swelling |
Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. ...
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Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
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| 45 | 2021-02-26 | swelling | Red, swollen, itchy blotch about an 1in (so far) sore to touch |
| 45 | 2021-02-27 | lymph node swelling |
5 minutes after the shot a sharp pain to the left side of my neck. Now my lymph nodes in the neck a...
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5 minutes after the shot a sharp pain to the left side of my neck. Now my lymph nodes in the neck are swollen.
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| 45 | 2021-02-27 | lymph node swelling | Headache, nausea, extreme fatigue, swollen glands, muscle aches |
| 45 | 2021-02-28 | lymph node swelling, lymph node pain |
Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contacta...
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Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.
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| 45 | 2021-02-28 | lymph node swelling |
Lymph nodes on left side swollen, Neck, upper shoulder/clavicle, & arm pit, Also right neck lymph no...
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Lymph nodes on left side swollen, Neck, upper shoulder/clavicle, & arm pit, Also right neck lymph node
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| 45 | 2021-03-01 | lymph node pain, c-reactive protein increased, lymph node swelling |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-01 | lymph node pain, lymph node swelling |
Chills, sweats, severe body aches, headache, fevers, diarrhea, severe pain and swelling under left ...
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Chills, sweats, severe body aches, headache, fevers, diarrhea, severe pain and swelling under left arm, fatigue, nausea
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| 45 | 2021-03-02 | lymph node swelling |
Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden,...
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Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic. Medical history included known Drug Allergy to: Sulfa and Cipro antibiotics.. Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1, Lot Number EN5318 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives, two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious. No treatment was given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.
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| 45 | 2021-03-02 | swelling | increased swelling and redness and neck tenderness and pain |
| 45 | 2021-03-02 | swelling | Extreme tired Headache Achy and sore body Swelling and pain in armpit. |
| 45 | 2021-03-03 | lymph node swelling |
After my second vaccine, I experienced chills, sweats, headaches, body aches, join pain. I went to O...
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After my second vaccine, I experienced chills, sweats, headaches, body aches, join pain. I went to Occupational Health due to a large lymph node I also had to my vaccine, which was the size of a lemon. I took Ibuprofen for pain medication and relief of my headaches.
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| 45 | 2021-03-04 | peripheral swelling |
Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that...
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Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that wedding band doesn?t even come close to fitting on finger (which has been worn for 15 years).
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| 45 | 2021-03-04 | peripheral swelling |
Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mi...
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Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mild rhabdomyolysis on 3/4/2021 given proteinuria, myoglobinuria, elevated CK - unknown etiology/trigger for rhabdo.
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| 45 | 2021-03-06 | peripheral swelling |
Vaccine appt was at 10:00 am. Lightheadedness for about 10 seconds immediately after left arm was i...
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Vaccine appt was at 10:00 am. Lightheadedness for about 10 seconds immediately after left arm was injected. Later in the evening hands were swollen as if they were retaining water.
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| 45 | 2021-03-07 | swelling |
redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg an...
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redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg and thigh
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| 45 | 2021-03-09 | swelling face |
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che...
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I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
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| 45 | 2021-03-11 | lymph node swelling, lymph node pain |
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from...
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The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
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| 45 | 2021-03-12 | lymph node swelling, lymph node pain |
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other co...
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Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other concerns. As of 3/13/21 still slight soreness.
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| 45 | 2021-03-15 | swelling |
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. ...
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After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
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| 45 | 2021-03-16 | lymph node swelling |
I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle ...
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I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle soreness, had fever of 99.4F and thought it was menopausal symptoms. After my second dose vaccine, my lymph nodes were visibly enlarged. I experienced muscle soreness, lymph nodes were enlarged, left side, had chills, sore throat, ear ache radiated towards my neck and had a viral pink eye. I felt very tired and had muscle aches. I had a fever of 99.4F, mostly chills and joint pain to my left shoulder, left hip and left knee. I also had 3 Covid swab testes which were all negative. I saw my doctor who performed a x-ray of the chest and has put off a mammogram test till April 2021. At this time I have not recovered there is something going on with my pelvis, form my iliac crest when bending down I feel a pinched lymph node on that area of iliac crest. I get a pinch on my pelvis that is painful.
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| 45 | 2021-03-17 | swelling |
Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin ...
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Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin at 4:30. An hr later c/o "flu like symptoms e.g. aches and pains, then had to take a nap. Woke up the next morning c/o soarness, itching, and self-administred Zyrtec 1 po in a.m then again in the p.m. Felt some relief but a little achey just flu-like. Most of Sunday felt the same but Sunday approx 6p broken out into red whelts on the chest and back, throat felt like it was starting to close in and I went to the ER at approximately 8 p.m. Was given Prednasone 10 day pack, and Benadryl both p.o. Did receive somewhat relief from the Rx. Nothing was done to airway. Continues to c/o itching underneath the skin
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| 45 | 2021-03-17 | swelling |
Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-he...
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Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-headed/dizzy. She appeared frightened and after a couple of minutes felt as if her lips were beginning to swell. Patient was offered and received benadryl liquid orally and felt better after 15 more minutes and left after declining any additional treatment.
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| 45 | 2021-03-18 | lymph node swelling |
Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days...
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Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days after shot. Fatigue Injection site soreness Mild headache
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| 45 | 2021-03-18 | swollen extremities, swelling, peripheral swelling |
Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. L...
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Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. Less than 24 hours I was in severe pain. Felt like my bones hurt. Swelling on the left side included my armpit and left side of the torso down to the waist. The pain stayed for another day. Felt like I had the flu. Swelling in the armpit and upper left torse stayed for about three weeks. Wednesday, March 17 I went to the ER for chest pains, throat tightening, pain from my shoulder to my hand on the left side.
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| 45 | 2021-03-19 | swelling |
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ...
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Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: cellulitis, growing erythema, swelling, heat. Given ATB-Medium, Additional Details: Pt given ATB for increased swelling, erythema, heat. Pt has daily tracked progression. Site circled, currently 14 cm today in L detoid. Lot number of COVID-19 immunization not available to NP in Clinic.
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| 45 | 2021-03-21 | anaphylactic reaction | anaphalaxis, epicene, benadryl, pepsid |
| 45 | 2021-03-21 | lymph node swelling |
Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swe...
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Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swelled to the size of a kiwi. Swelling gradually reduced over 2 days to the size of a large grape. Very hot and painful. I have never had such an extreme reaction to a vaccine.
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| 45 | 2021-03-21 | swelling face |
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st...
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after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
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| 45 | 2021-03-21 | swelling |
Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and hea...
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Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and headache
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| 45 | 2021-03-21 | swelling |
Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I wa...
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Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I was waiting, my left should (upper left side of my back) started aching. I do not normally have any kind of a response to any vaccine, so I didn't immediately connect this pain with my COVID-19 vaccine, however, it continued to get progressively worse and ultimately became my entire arm, shoulder, neck and head. I had a lot of difficulty sleeping for the next two nights and I noticed yesterday morning (Sunday, 3/21/21) that my left clavicle was completely obscured by significant swelling (I assume lymphnodes). Golf ball-sized swelling. Today (Monday, 3/22/21) the swelling continues to be significant and I think maybe covering more area. Not as pronounced of a lump, but more of a squashed, larger lump, if that makes sense?
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| 45 | 2021-03-22 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on f...
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Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on face, neck, and exposed area of chest that started four days after receiving vaccine. Lymph nodes are also swollen. Denies chest pain, shortness of breath, flu-like symptoms, fever, itching, or swelling at injection site. Patient has experienced urticarial symptomns with upper repiratory infections in the past. Provider recommended diphenhydramine and home management.
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| 45 | 2021-03-22 | swelling face |
48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subs...
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48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subsiding after day 3 of benadryl
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| 45 | 2021-03-22 | swelling |
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sor...
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lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
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| 45 | 2021-03-23 | lymph node swelling |
swollen lymph nodes, Muscle and body aches, Fatigue, Headache, chills. The symptoms last for four d...
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swollen lymph nodes, Muscle and body aches, Fatigue, Headache, chills. The symptoms last for four days.
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| 45 | 2021-03-23 | swelling |
First Vaccine was 1/13/21 same location. I received the 2nd dose of the COVID-19 Vaccine (Pfizer) on...
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First Vaccine was 1/13/21 same location. I received the 2nd dose of the COVID-19 Vaccine (Pfizer) on 2/3/21. On 2/4/21 I had body aches, headache, low grade fever, joint pain. On 2/5/21 Fever up to 102, severe body aches and headache and joint pain. By 2/6/21, most S/S had gone no more fever or body aches. However, I noticed significant swelling Left shoulder blade and arm pit. Left shoulder was painful to touch and arm pit was sore. The headache continued but milder now located almost completely at base of skull. By 2/17/21 I noticed the swelling in Left shoulder blade had gone down, however the armpit remained very swollen. Also, in addition I have a lot of bilateral swelling in my neck most noticeable right above my clavicle on both sides. This swelling is also painful and my neck is very stiff and painful to turn to the sides. I saw my PCP on 3/19/21 regarding as I am now over 6 weeks post vaccination.
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| 45 | 2021-03-25 | swelling face |
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la...
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Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
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| 45 | 2021-03-25 | swelling |
Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning T...
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Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning Tuesday, 3/23/2021, one day after dose: Rash Symptoms beginning Thursday, 3/25/2021: Itching
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| 45 | 2021-03-26 | swelling |
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from rig...
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Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
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| 45 | 2021-03-28 | lymph node swelling | swollen lymph node |
| 45 | 2021-03-28 | white blood cell count increased |
On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to EN...
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On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to ENT on 1/11, diagnosed with acute on chronic sinusitis, prescribed Augmentin & Prednisone to start 48 hours after 2nd vaccine dose. Sinusitis did not explain headache as I've never presented with headache in the past. 2nd vaccine dose 1/14/21; began Augmentin & Prednisone on 1/16 (wanted to hold off on treatment until after 2nd vaccine dose). Headache continued & began to worsen. I thought maybe due to prednisone or high blood pressure from prednisone? Visit to PCP on 1/25 due persistent headache that was not resolving (Headache was vice-like, pain moderate to severe, headache worse with exertion or bending over). 1/25 "worst headache of my life". MRI ordered & completed 1/27; MRI normal other than sinusitis. Visit to ENT on 1/28; she said sinusitis improving & prescribed Norco for headache pain. Visit to PCP on 1/30; he prescribed Gabapentin & Naproxen for headache pain. Visit to Naturopath on 2/4; recommended adding Magnesium & B Vitamin Complex. 2/5: Massage with worsening headache pain. 2/10: Chiropractor & Acupuncturist with worsening headache pain. 2/19: Visit to Urgent Care for Toradol shot & Cyclobenzaprine prescribed. 2/23: Visit with Neurology; prescribed Topamax & Prednisone. 3/5: felt strange sensations in body, wave like feeling over limbs, tension in skull, heart pounding, change of hearing, menthol sensation on skin, change of taste, worsening headache, warm feeling in chest & abdomen, lasts 1-2 minutes. 3/6: ED visit due to strange episode/sensations; Neurologist on call prescribed Fioricet & Nortriptyline. 3/9: visit to Neurology, she increased metoprolol to 50mg, injected Ajovy, prescribed more cyclobenzaprine & ordered MRI/MRV. Headache pain continued to be moderate to severe, constant & "nervy", episodes continued to occur daily. 3/12: bloodwork to check inflammation. 3/14: MRI/MRV completed. Headache worsened with MRI noise & injection of contrast. 3/16: lumbar puncture completed w/ normal pressure, awaiting CSF labs. Discontinued Topamax 3/21; thought maybe contributing to episodes. More bloodwork completed 3/24. Visit to PCP, given Nurtec sample with some relief. Otherwise, headache remains daily & persistent with little/no relief overall. Head pain is bilateral, vice-like, burning sensation @ times on skull or face, numbness & tingling both sides of face periodically. Headache worsens with activity & at night. Episodes (strange sensations) continue to occur 1-3x/day, usually when laying down, at night or in morning.
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| 45 | 2021-03-29 | peripheral swelling, swelling face |
Pain in shoulder, neck and wrist. Swelling of face under eyes and cheeks. Swelling in hands and f...
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Pain in shoulder, neck and wrist. Swelling of face under eyes and cheeks. Swelling in hands and feet.
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| 45 | 2021-03-30 | lymph node swelling, lymph node pain |
It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headac...
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It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headache and was running a fever. Later, the lymph node under my arm on the side of the injection was swollen and a little painful.
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| 45 | 2021-03-30 | lymph node swelling, peripheral swelling |
lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft ti...
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lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported), at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury. Information about Batch/Lot number has been requested.
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| 45 | 2021-03-30 | lymph node swelling |
1.) Right axillary lymphadenopathy starting the morning following the injection (3/30/21) and not re...
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1.) Right axillary lymphadenopathy starting the morning following the injection (3/30/21) and not resolved at the time of this report. Slight discomfort associated with the lymphadenopathy when right arm positioned or held close to body. Took 200mg Ibuprofen before bed on 3/30/21 to help with discomfort. 2.) Body chills noted throughout the day on 3/30/21. Resolved as of 3/31/21. Not associated with a fever. No treatment. 3.) Headache noted throughout the day on 3/31/21. Resolved as of 3/31/21. No treatment.
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| 45 | 2021-03-30 | lymph node swelling |
Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Heada...
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Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
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| 45 | 2021-03-30 | peripheral swelling |
Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and resc...
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Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and rescue inhaler
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| 45 | 2021-03-30 | swelling | Red swollen area warm to the touch and itchy 8 days after vaccine |
| 45 | 2021-03-31 | axillary mass | Headache, severe body aches, lump in left arm pit, and chills which lasted 24 hrs. |
| 45 | 2021-04-01 | lymph node swelling |
it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her...
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it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her head and last night aching on left side of her head; Eyelids with poking sensation; lip is jerking, jerking of eyes; pain on left side of her neck; I feel my gland is swollen with a lump on left side; I have had tingling and a needle pain sensation all over my body./Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head; Has to work through the pain/Pain ran down along left side of neck a couple of nights ago also;; Left top of head aching sensation; It is effecting her work and daily life.; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: not reported via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 14:25 (at the age of 45-years-old) as single dose for COVID-19 immunization. Medical history included ongoing hepatitis B, Kidney stone from 2019 and ongoing. Concomitant medication(s) included tenofovir disoproxil fumarate (Dosage text : 300mg Tablet once daily at night) taken for hepatitis b. The patient's father has high blood pressure and heart problems and mother is fine as stated. The patient experienced tingling and a needle pain sensation all over my body/tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head on 07Mar2021, had to take benadryl to sleep on an unspecified date with, eye lid tingling on an, on 16Mar2021 lip is jerking, pain on left side of her neck, feel the gland is swollen with a lump on left side, also reports pain on the top of her head and last night aching on left side of her head, eyelids with poking sensation, jerking of eyes, left top of head aching sensation, it is effecting her work and daily life, has to work through the pain/pain ran down along left side of neck a couple of nights ago. Therapeutic measures were taken as a result of insomnia. The outcome of event Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head, Lips Jerk, Jerking of Eyes, Left side of neck lump like a swollen lymph is Not Recovered, Left top of head aching sensation, Pain ran along left side of neck is Recovered. Follow up (17Mar2021): New information included clinical information and description of product complaint: Is there a Product Complaint: Taking benadryl last two nights to sleep, did not help last night. Product strength and count size dispensed: 25mg. Additional lot numbers: P117225. Is a sample of the product available to be returned, if requested: No No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal association, a causal relation between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-02 | swelling | Fever, chills, headache, neasea, fever, swelling & redness at injection site, dizzy |
| 45 | 2021-04-03 | lymph node swelling, lymph node pain | Painful swelling of lymph nodes near collarbone |
| 45 | 2021-04-03 | lymph node swelling |
Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. ...
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Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. Swollen lymph nodes in armpits and under jaw. Bed rest, sleep, daytime/nighttime cold medicine, liquids.
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| 45 | 2021-04-21 | peripheral swelling |
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist....
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arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
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| 45 | 2021-04-24 | white blood cell count increased |
Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise...
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Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg. CBC and CMP clinically unremarkable with no elevation of white blood cell count. HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108. No acute ST or T abnormalities. No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative. ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given. A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine, but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both... Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
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| 45 | 2021-04-26 | sepsis | fever, arm pain, sepsis |
| 45 | 2021-04-28 | peripheral swelling |
As described by the patient: As they were putting the vaccine, the area got really warm, and the ar...
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As described by the patient: As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm. As time passed (15 minutes), the warm feeling flowed to my should and left side of my back. Another 15 min passed, and it moved down my left leg and knee, which started to hurt. Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and
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| 45 | 2021-05-04 | swelling face, peripheral swelling |
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha...
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Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-05-09 | white blood cell count increased, lymph node swelling, c-reactive protein increased |
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau...
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Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
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| 46 | 2021-01-02 | swelling face |
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs...
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Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
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| 46 | 2021-01-04 | anaphylactic reaction, peripheral swelling |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | swelling face |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | swelling, swelling face, anaphylactic reaction |
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of...
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Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
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| 46 | 2021-01-05 | lymph node swelling |
3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of...
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3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face. Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.
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| 46 | 2021-01-05 | swelling |
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ...
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UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
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| 46 | 2021-01-06 | lymph node pain | fever 100.3, lymph pain, body aches |
| 46 | 2021-01-06 | lymph node swelling |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | lymph node swelling |
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj...
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12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
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| 46 | 2021-01-06 | lymph node swelling |
Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & nec...
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Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling. Had both regular and Rapid covid test and rapid was negative. Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.
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| 46 | 2021-01-06 | swelling face |
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris...
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01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
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| 46 | 2021-01-06 | swelling, swelling face |
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ...
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Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
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| 46 | 2021-01-07 | lymph node swelling |
Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and pain...
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Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.
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| 46 | 2021-01-07 | lymph node swelling |
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli...
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left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
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| 46 | 2021-01-08 | lymph node swelling | Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache |
| 46 | 2021-01-08 | swelling face, swelling |
Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZ...
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Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZER injection. Employee did not experience any SOB or chest pain. ER provider administered steroid injection for treatment. Employee returned to work on the day of discharge and states she will follow up with private allergist for further disposition.
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| 46 | 2021-01-10 | lymph node swelling, swollen extremities |
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1...
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Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
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| 46 | 2021-01-10 | lymph node swelling | Golf ball size lymph node in left axilla, mild tingling in left arm |
| 46 | 2021-01-11 | lymph node swelling | Severe under armpit swelling with severe pain to the left side . Swollen lymph nodes |
| 46 | 2021-01-11 | peripheral swelling |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-12 | lymph node pain, lymph node swelling |
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin...
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Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
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| 46 | 2021-01-12 | lymph node swelling |
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was fee...
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Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
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| 46 | 2021-01-12 | lymph node swelling | Headache, fatigue, swollen lymph nodes, chills, fever |
| 46 | 2021-01-13 | peripheral swelling | swelling of arm vaccine administered in, redness at injection site, chills |
| 46 | 2021-01-13 | swelling face |
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,...
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Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
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| 46 | 2021-01-13 | swelling face | Swollen face, wheezing |
| 46 | 2021-01-14 | lymph node swelling | achy, chills, swollen lymph node, tired, headache |
| 46 | 2021-01-14 | peripheral swelling |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-15 | peripheral swelling |
Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection si...
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Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection site.
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| 46 | 2021-01-15 | swelling face, swelling |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-15 | swelling face |
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f...
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Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
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| 46 | 2021-01-16 | swollen extremities, swelling |
Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday ...
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Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday I woke up with a severely swollen armpit and anterior chest
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| 46 | 2021-01-17 | peripheral swelling |
SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now ...
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SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now the size of a baseball and growing. hot panful and tender to touch
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| 46 | 2021-01-18 | lymph node swelling |
I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started ...
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I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started with cough and the need to keep clearing my throat. By 9 pm, I felt like my lymph nodes in my neck were swollen, my throat was getting sore, and my head was starting to throb. I took 2 tylenol and went to bed. I woke up at 3 am with a 101.6 temp and body aches. By 8 am on 1/13/2021, I could not lift my own body out of bed or roll over. The fever and body aches continued around the clock for 55 hrs. The headaches are debilitating and continue. I have tried Tylenol, Ibuprofen, Excedrin, and Imitrex and none of these have helped. I missed 3 days of work and 2 weekend days trying to recover and i am still not back to normal. Headaches are still happening everyday. At one point in the middle of this, i felt like I should go to the hospital, but I was too sick to get out of bed and shower and make myself go.
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| 46 | 2021-01-18 | lymph node swelling | Lymph node on my right collar bone |
| 46 | 2021-01-18 | peripheral swelling |
On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/20...
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On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
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| 46 | 2021-01-18 | swelling |
Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon...
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Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
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| 46 | 2021-01-18 | white blood cell count increased |
Patient had received second Pfizer vaccination after no reported issues with the first dose. Patien...
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Patient had received second Pfizer vaccination after no reported issues with the first dose. Patient was observed post vaccination without incident and released. Patient developed wheezing and attempted to treat with her albuterol inhaler but did not improve. patient presented to the ED approximately 2 hours after vaccination and was admitted for respiratory failure and placed on BiPAP for a brief period of time. patient has known history of Asthma Exacerbation requiring hospitalization and intubations. D/C diagnosis Asthma Exacerbation
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| 46 | 2021-01-19 | lymph node swelling |
about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm tha...
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about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm that i received the vaccine in. then i became tired and developed a headache, fever and sore throat. that lasted a few days and has since resolved. i was tested for covid after to make sure i did not contract the virus at my place of employment. it was negative.
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| 46 | 2021-01-19 | swelling, lymph node swelling |
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen...
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the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
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| 46 | 2021-01-20 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 46 | 2021-01-20 | axillary mass |
Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after t...
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Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after that; fatigue; Lump in left armpit area; second dose on 08Jan2021/first dose on 22Dec2020; second dose on 08Jan2021/first dose on 22Dec2020; This is a spontaneous report from a contactable Other HCP (patient). A 46-year-old female patient received the second dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. Medical history included thyroid condition. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of BNT162b2 (Lot number: EL1284), at the age of 46-year-old, via an unspecified route of administration in left arm at single dose on 22Dec2020 15:30 for covid-19 immunization. The patient experienced severe debilitating headache that she wondered if she should go to ER for. Fever 103 lasting 24 hours, coming down to 100 after that. Unable to get out of bed for 24 hours due to fatigue, fever and severe headache. Lump in left armpit area. The above events were occurred at 20:30 on 08Jan2021. The patient did not receive the treatment for the above events. The patient received the first dose on 22Dec2020, second dose on 08Jan2021. The patient was not pregnant. The patient underwent lab tests and procedures which included body temperature: 103 on 08Jan2021, 100 in Jan2021. The outcome of the events headache, fever, fatigue, Axillary lump was recovering.
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| 46 | 2021-01-21 | lymph node swelling |
8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlar...
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8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlarged, and right breast pain and swelling started. Symptoms impeded function of arm. Seen by a provider on 1/19/2021
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| 46 | 2021-01-21 | lymph node swelling |
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to...
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I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
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| 46 | 2021-01-21 | swelling face |
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f...
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Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
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| 46 | 2021-01-22 | peripheral swelling | localized reaction to left arm with erythema swelling and warmth |
| 46 | 2021-01-23 | lymph node swelling | Muscle aches and swollen lymph nodes |
| 46 | 2021-01-24 | swelling |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-25 | lymph node swelling |
Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report f...
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Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 10:30 on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on an unspecified date. The patient experienced extreme body achees, severe headache, lymphadenopathy in the armpit, all at 21:30 on 11Jan2021. Adverse reactions did not result any serious consequences. Facility type vaccine was hospital. No need treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Other medical history was none. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 46 | 2021-01-25 | lymph node swelling |
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3...
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day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
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| 46 | 2021-01-26 | lymph node pain, lymph node swelling |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-26 | swelling face |
right side under her eye was swollen; right side of face was swollen; This is a spontaneous report f...
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right side under her eye was swollen; right side of face was swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient reported she had the first shot on yesterday (12Jan2021); it was given by a nurse at the hospital where she works. Last night, she noticed on the same side that she got shot, her right side under her eye was swollen and the right side of her face was swollen too. She wanted to know what to do and wanted to know if they were side effects. No therapeutics measures were done in response to the events. At the time of last observation, events' outcome was not recovered. Information about Lot/Batch number is requested.
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| 46 | 2021-01-29 | lymph node pain |
Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vac...
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Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vaccine. That has recovered in 75% since onset of symptoms. Pt claims tenderness in the right neck area, with a non visible but palpable lump the size of a quarter. Patient took a dose of tylenol 1g which subdued most of the symptoms, and reports today 1/30/2021 only local tenderness, with no other side effects to report. Pt also claims feeling of chills, and flu like symptoms 24 hours after the vaccination which subdued with a dose of Tylenol 1g.
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| 46 | 2021-01-30 | lymph node swelling, lymph node pain | Lymph nodes under left arm pit very swollen and tender for 5 days now. |
| 46 | 2021-01-31 | lymph node swelling, lymph node pain |
Tenderness and induration without erythema at injection site that wrapped around outer arm, under ax...
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Tenderness and induration without erythema at injection site that wrapped around outer arm, under axilla and produced tender axillary lymphadenopathy . This occurred within 24 hours of vaccination and is still present 84 hrs after vaccination.
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| 46 | 2021-01-31 | lymph node swelling |
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary nod...
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mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site. Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
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| 46 | 2021-01-31 | lymph node swelling |
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee...
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severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
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| 46 | 2021-01-31 | swollen extremities |
Patient called to report that after receiving her vaccine on Friday: during the middle of the night ...
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Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had. She also states that her Right arm pit is swollen
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| 46 | 2021-02-02 | peripheral swelling |
Extreme swelling of Axillary area of right arm. Ibuprofen, Pepcid and Loratidine - Swelling went fr...
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Extreme swelling of Axillary area of right arm. Ibuprofen, Pepcid and Loratidine - Swelling went from Softball size to golfball size with first 2 days of medication therapy. Swelling continues to reduce with additional doses.
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| 46 | 2021-02-02 | swelling | Cellulitis, redness, swelling, hard lump, heat, tired, headache, pain |
| 46 | 2021-02-03 | peripheral swelling |
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm...
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really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
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| 46 | 2021-02-04 | swelling |
left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-ye...
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left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL9261), intramuscular at Arm Left on 18Jan2021 11:15 at the 46 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medication was ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc(CENTRUM MULTIGUMMIES). The Historical Vaccine was fist dose BNT162B2 for COVID-19 immunization. The patient previously took Iodine and experienced allergy. There was no other vaccine in four weeks. The patient experienced left axillary swelling on 19Jan2021 22:00. There was no treatment received for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the event was not recovered.
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| 46 | 2021-02-06 | axillary mass | Soreness and a large "nodule" to right axillary |
| 46 | 2021-02-06 | swelling face, lymph node swelling |
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch...
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On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
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| 46 | 2021-02-07 | peripheral swelling | pt verbalized tingling in hands and swelling in hands post vaccination. |
| 46 | 2021-02-07 | swelling |
When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt...
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When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt like my right side of my throat was sweet and then my asthma kicked in , I used my inhaler and I few hours all my symptoms went away.
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| 46 | 2021-02-08 | lymph node swelling | Left arm pit lymph swelling and tightness of Internal rotation muscles |
| 46 | 2021-02-08 | lymph node swelling |
Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadr...
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Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
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| 46 | 2021-02-09 | lymph node swelling |
Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, ...
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Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, mainly my neck, stomach and back Day 10 Left eye is swollen and pain on eyelid and behind eye lid
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| 46 | 2021-02-10 | lymph node swelling |
- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymp...
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- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymph node on Ipsilalent side of shot - Concentration off BLOOD SUGARS SLIGHT Elevation (129-132 fasting) Decrease in Blood Pressure to 104/76 (usually 120s to 130s/80s
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| 46 | 2021-02-10 | oral herpes |
Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persist...
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Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persists. Slight lightheadeness with exertion, "bad HA," slight ST. During call patient looked in mirror and noted fullness in upper lip with new "cold sore" and lightly flushed forehead w/ flat, non-pruritic, red rash. Denies SOB, wheezing, swelling of tongue or throat. Denies dyphagia, eye swelling. Instructed patient to see provider at clinic now (she is in clinic now) and be evaluated.
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| 46 | 2021-02-10 | swelling | Left knee pain, swelling; using leg brace, OTC topicals. |
| 46 | 2021-02-11 | swelling |
First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day ...
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First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day my boss was home with Covid. I did a Saliva test (covid test), while waiting for my test above my collar bone was swollen. I was generally not feeling well. I got my results on the 25th and it was negative. On the 30th I got heart fluttering, feelin racy. It went away. On the 1st, I felt so wiped out and heart was going nuts, and I went to get a EKG that was normal but my BP was high140/high 80. On the 4th I went back to work again and still felt horrible, dizzy and they sent me to the ER and had High BP and two normal EKG', and the hooked me up to a heart monitor for a week. With both shots I had insomnia of the walls. Second Dose: it was much better than 1st dose. The Monday after the 2nd dose I got a really bad headache. I drank some Pedialyte and took a 12 hour nap and felt great after.
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| 46 | 2021-02-12 | swelling |
I started itching on my limbs approximately 2 hours post injection. This moved to my trunk about 30 ...
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I started itching on my limbs approximately 2 hours post injection. This moved to my trunk about 30 min after that. I had several raised red spots at this time. I took OTC Pepcid initially and at bedtime I took 2 benedryls. This relieved all symptoms.
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| 46 | 2021-02-13 | lymph node swelling | Pfizer-BioNTech COVID 19 Vaccine EUA LYMPH NODE SWELLING IN RIGHT ARMPIT and Pain. |
| 46 | 2021-02-16 | lymph node swelling |
Swollen lymph nodes and pain in left underarm (side where shot was given), first noticed approximate...
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Swollen lymph nodes and pain in left underarm (side where shot was given), first noticed approximately 10pm on the evening following vaccination. As of this report, lymph nodes are still swollen (12 days post-vaccination, 11 days since appearing) but less painful.
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| 46 | 2021-02-22 | swelling face | Heaviness in chest. Swelling on face , eyes and lips |
| 46 | 2021-02-24 | anaphylactic reaction |
Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptom...
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Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.
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| 46 | 2021-02-24 | lymph node swelling | swollen and sore lymph nodes in armpits - neck and groin area. not resolved at this time |
| 46 | 2021-02-26 | axillary mass, lymph node swelling |
Swelling in armpit. There is a large painful lump in my armpit. I noticed the pain the morning after...
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Swelling in armpit. There is a large painful lump in my armpit. I noticed the pain the morning after the shot. I checked in the afternoon and saw the lump.
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| 46 | 2021-02-27 | lymph node swelling, lymph node pain |
Swollen lymph nodes under the arm in the arm pit area. Very painful and swollen Swollen lymph node ...
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Swollen lymph nodes under the arm in the arm pit area. Very painful and swollen Swollen lymph node in the neck right above the clavicle. Very painful and swollen Started about around 24-27 hours after the injection Ice bags on both sites at least 2 times per day since symptoms started Took to iuphopens to help with pain/swelling
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| 46 | 2021-02-28 | lymph node swelling |
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest an...
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headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
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| 46 | 2021-02-28 | peripheral swelling | arm swelling, tenderness, armpit swelling |
| 46 | 2021-03-01 | lymph node swelling, peripheral swelling |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-04 | lymph node pain, lymph node swelling |
Swollen and painful lymph nodes around right side colar bone. I have not seen a doctor about this b...
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Swollen and painful lymph nodes around right side colar bone. I have not seen a doctor about this but I read that it should go away within 3 weeks.
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| 46 | 2021-03-04 | lymph node swelling |
Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post sh...
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Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post shot painful lymph node pain under left arm and side of breast
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| 46 | 2021-03-04 | swelling |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth /...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Approximately 30 minutes after administration, patient reported some difficulty breathing and extreme lightedheadness. Breathing was shallow. Also reported swollen tongue, which led to slurred speech. Benadryl was immediately given and patient was monitored for an additional hour. At the end, patient reported she felt better and speech improved, but still lightheaded like she \"just had 2 glasses of wine.\"
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| 46 | 2021-03-07 | lymph node swelling | Swollen axillary lymph nodes in left arm pit with left breast pain |
| 46 | 2021-03-08 | lymph node pain, lymph node swelling |
Received dose on 01/12/2021 - left arm - muscle soreness. however on 01/14/2021 developed left axil...
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Received dose on 01/12/2021 - left arm - muscle soreness. however on 01/14/2021 developed left axillary lymph node became very swollen and very painful -discomfort. Also became very fatigued and temperature not stable bouncing down to 97.4 - 99.9. these all lasted for about 3 days and then completely went away
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| 46 | 2021-03-09 | lymph node swelling |
pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional num...
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pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional numb sensation down left arm into wrist and fingers.
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| 46 | 2021-03-09 | peripheral swelling |
Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing h...
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Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing heart rate then episodes of chills and sweating. The next day I had a hard time holding my tooth brush, pain and swelling to both hands and severe pain in left foot. When I get up from sitting position to walking it feels like my bones in my left foot will shatter. The pain is very bad even in bed when I?m not moving.
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| 46 | 2021-03-10 | lymph node swelling |
Swollen lymph nodes right armpit day after injection, fatigue, dizziness was only immediately after ...
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Swollen lymph nodes right armpit day after injection, fatigue, dizziness was only immediately after injection but subsided, chills are off and on mild.
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| 46 | 2021-03-11 | lymph node swelling | extreme headache, flush face, flu like symptoms and swollen lymph note under right arm |
| 46 | 2021-03-11 | sepsis |
patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patie...
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patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patient with multiple comorbidities: Bipolar disorder, parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, sleep apnea. H/O CVA, has sacral decubitus and cellulitis of pannus. presents with sepsis likely secondary to cellulitis of pannus. Admitted for care then discharged on 2/26
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| 46 | 2021-03-12 | lymph node pain, lymph node swelling | Swelling and tenderness in left arm pit and chest area |
| 46 | 2021-03-14 | lymph node pain, lymph node swelling |
March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (...
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March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (~3:00pm) noticed itchy neck and face. (Since I had a rash last year from skincare products I just thought it was same thing). March 11, rash worse. Treated with topical 2.5% hydrocortisone ointment. Back of head started feeling tender. March 12, evening, back of head feeling worse, took Ibuprofen. Rash much better on face/neck. Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head. March 13, 8:00am, went to urgent care clinic. Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes. Rash almost gone. Back of head extremely tender/painful. March 14, swollen lymph nodes multiplied on back of head and also on right side of neck. Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine. March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain. Spreading more in right side of neck, which is sore/tender. Slight rash on neck.
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| 46 | 2021-03-14 | lymph node swelling |
Lymph node in neck (collar bone area) is swollen on the same side I received the shot on. (Left Arm...
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Lymph node in neck (collar bone area) is swollen on the same side I received the shot on. (Left Arm/Side)
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| 46 | 2021-03-14 | swelling face |
I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my...
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I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my teeth and lips. My throat felt full and I was coughing slightly. Within an hour and 10 minutes after the injection, I started to feel back to normal.
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| 46 | 2021-03-15 | lymph node swelling |
ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTE...
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ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTED APPROXIMATELY 2 WEEKS
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| 46 | 2021-03-15 | swelling face, lymph node pain |
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ...
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25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
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| 46 | 2021-03-15 | swelling face |
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, c...
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Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
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| 46 | 2021-03-16 | lymph node swelling |
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of t...
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I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
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| 46 | 2021-03-16 | swelling |
03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very...
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03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off. 03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed. 03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well. 03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued. 03/15/21 ear still sore some throat better than before went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
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| 46 | 2021-03-17 | lymph node swelling |
Euphoria (ongoing), golf ball size lymph node in left armpit (ongoing), and short-term menstrual cra...
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Euphoria (ongoing), golf ball size lymph node in left armpit (ongoing), and short-term menstrual cramps with light spotting (I have not had a period for over a year, and I haven't had cramps in several years).
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| 46 | 2021-03-17 | lymph node swelling |
Swollen lymph node in right armpit started about a week after the vaccination. It?s been a week and ...
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Swollen lymph node in right armpit started about a week after the vaccination. It?s been a week and has not subsided.
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| 46 | 2021-03-17 | swelling |
Small tender supraclavicular bump; has not noticed any other side effects. feels fine. We rec to use...
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Small tender supraclavicular bump; has not noticed any other side effects. feels fine. We rec to use warm compress/NSAIDS and see her MD if this persists past 10 days.
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| 46 | 2021-03-18 | lymph node swelling |
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la...
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On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
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| 46 | 2021-03-18 | swelling |
24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. ...
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24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. I noticed two bumps near my clavicle, as well that area is swollen.
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| 46 | 2021-03-19 | lymph node swelling, lymph node pain |
Significant swelling in right armpit (lymph nodes) with mild to moderate pain/ache in same area, goi...
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Significant swelling in right armpit (lymph nodes) with mild to moderate pain/ache in same area, going on 2 days now.
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| 46 | 2021-03-19 | swollen extremities | Lasting 4 days- Nausea, vomiting, aches, fatigue, fever, chills Lasting 2.5 weeks -Leg edema |
| 46 | 2021-03-20 | lymph node swelling | Enlarged and tender lymph nodes in left armpit |
| 46 | 2021-03-20 | swelling face |
Facial swelling noticed about and hour and a half after shot. Swelling is through entire face but m...
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Facial swelling noticed about and hour and a half after shot. Swelling is through entire face but more noted on right hand side. Noted massive headache and dizzy spell twice lasting no more than a minute each time. Taken Benadryl every 6 hours after noticing facial swelling.
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| 46 | 2021-03-21 | lymph node swelling |
Day after injection: Swollen arm around injection site. Day two after injection: After swelling decr...
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Day after injection: Swollen arm around injection site. Day two after injection: After swelling decreased I had swelling under my arm with a knot the size of a golf ball. Very sore and tender to touch.
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| 46 | 2021-03-21 | lymph node swelling | Swollen right tonsil, swollen lymph nodes in neck and jaw, pain, no fever, tested negative for strep |
| 46 | 2021-03-21 | peripheral swelling |
severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card...
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severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
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| 46 | 2021-03-22 | lymph node swelling |
Small lump in armpit, slightly painful and uncomfortable when lowering the arm. The lump comes and ...
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Small lump in armpit, slightly painful and uncomfortable when lowering the arm. The lump comes and goes and so does the pain and discomfort. This started the morning after the vaccine and is still continuing on day two post vaccine
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| 46 | 2021-03-22 | peripheral swelling | Swelling of right hand, extreme itchiness, some redness |
| 46 | 2021-03-23 | swelling face |
Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I...
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Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I emailed my GP with pictures and took antihistamine and went through it. It lasted ~ 5 days. Important to note that I have had 2 episodes of face swelling in July and August 2020 of unknown cause. Swelling is gone and
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| 46 | 2021-03-23 | swelling |
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th ...
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"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days. This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days. It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
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| 46 | 2021-03-24 | lymph node swelling |
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu...
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congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
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| 46 | 2021-03-24 | peripheral swelling |
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot a...
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Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling. Within 5-10 minutes she developed a rash on hands, face, neck and chest. She notified the staff, who provided ice packs for the swelling and placed her in front of a fan. She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems. She began developing a mild headache. She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses. She took Tylenol for headache. The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
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| 46 | 2021-03-24 | swelling |
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes...
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Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
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| 46 | 2021-03-25 | lymph node swelling |
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi...
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Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
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| 46 | 2021-03-26 | swelling, swelling face, peripheral swelling |
On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm...
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On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm/breast area on the left side .By the afternoon all swelling was gone except under the arm. It is uncomfortable to put my arm close to my body and to lay on that side today. It is still sore and swollen today.
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| 46 | 2021-03-28 | lymph node swelling |
Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resul...
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Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
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| 46 | 2021-03-28 | peripheral swelling, lymph node swelling |
Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and...
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Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and armpit on vaccine side, chills, fever of 101.2 for 48 hours, severely painful joints, fatigue. Hot flashes, feeling of chills improved but persists even 5 days after
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| 46 | 2021-03-30 | swelling face |
3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bla...
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3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
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| 46 | 2021-03-30 | swelling |
tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as banan...
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tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as bananas and ice cream taste very sugary and fries taste peppery and some foods don't have any taste. 20 minutes after vaccine my tongue felt swollen and under my chin felt swollen. Swelling was mild and went away after an hour or 2.
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| 46 | 2021-03-31 | swelling face |
Bilateral severely swollen ankles, facial swelling noticed approximately 6-7 hours post vaccine; swe...
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Bilateral severely swollen ankles, facial swelling noticed approximately 6-7 hours post vaccine; swelling lasted approximately 3 days.
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| 46 | 2021-04-01 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient presented with soarness in throat a couple of hours after administration. SHe was taken to the fire department (Uncertain about what treatment was conducted here). Next day, and patient is still not fully recovered. Still has scracthy throat and soreness in her throat.
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| 46 | 2021-04-01 | swelling |
Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed a...
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Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed and "shaky" all inside. Angioedema was noted by vaccinator and patient was escorted to the Emergency Department. In the ED, the patient reported chest feeling tight, difficulty swallowing, shortness of breath, and feeling itchy. ED physician noted she was feeling anxious and noted no angioedema and that oxygen saturation was 100% on room air. 50 mg of IV diphenhydramine and 1 mg IV lorazepam were administered. Patient was discharged from the emergency department with a prescription for Medrol dosepak.
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| 46 | 2021-04-02 | lymph node swelling |
Day 5-lymph nodes in neck/behind collar bone on injection side swelled and became sensitive. Still s...
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Day 5-lymph nodes in neck/behind collar bone on injection side swelled and became sensitive. Still slightly swollen on day 17 but sensitivity had faded by day 14; day 7-2?x3? reddened area appeared at injection site; no itching or sensitivity; faded by day 11.
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| 46 | 2021-04-03 | white blood cell count increased, lymph node swelling, swollen extremities |
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S...
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She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
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| 46 | 2021-04-06 | swelling |
Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side o...
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Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-12 | anaphylactic reaction |
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla...
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skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-18 | lymph node swelling |
101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a s...
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101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Apr2021, at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Obesity, Hypothyroidism and High blood pressure. Allergies to medications, food, or other products was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included levothyroxine, amlodipine and rosuvastatin. The patient had not received any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in right arm, on 11Mar2021 at 15:00 for COVID-19 immunization. On 01Apr2021, at 21:00 the patient experienced 101F fever, chills, headache, fatigue, swollen lymph nodes in armpit and right clavicle. The therapeutic measures were taken as a result of events include extra sleep, extra fluids and acetaminophen. The patient underwent laboratory tests and procedure included body temperature resulted in 101 Fahrenheit on 01Apr2021. The outcome of the events was recovering. Information about batch/Lot number has been requested.
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| 46 | 2021-04-20 | lymph node swelling |
1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous,...
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1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous, muscle ache, chills, swollen under arm lymph node (L) Mass on left thyroid lobe
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| 46 | 2021-04-21 | swelling face |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
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| 46 | 2021-04-22 | guillain-barre syndrome | Guillian Barre Syndrome |
| 46 | 2021-04-24 | peripheral swelling |
mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm...
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mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-27 | anaphylactic reaction |
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ...
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Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 46 | 2021-04-30 | swelling |
angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-ol...
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angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, degenerative disc disease, migraines, allergies: shellfish intolerance, nickel allergy, skin allergy to some kind of plastic/foam. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); sertraline; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); minocycline. The patient experienced angioedema of left lower lip on 16Apr2021 01:00. The patient was given methylprednisolone 4 mg dose pack as treatment for the event. The patient has no prior vaccination and no covid test post vaccination. The patient had not recovered from the event at the time of the report.
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| 46 | 2021-05-04 | lymph node pain |
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency...
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Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-05-04 | lymph node swelling |
Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radia...
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Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radiating down arm and up neck. Swollen painful lymph nodes under arms and in neck (worse on side of injection) Treatment: benedryl and tylenol/advil. significant swelling and itching, blistering and lymph node swelling resolved on 5/42021. Minor itching and radiating pain continue, but are lessened by advil/tylenol and benedryl.
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| 46 | 2021-05-09 | lymph node swelling |
Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and som...
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Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and some drainage in the ear for 1 day. Arm pit was swollen for 3 days after which the swelling went down but site was still tender to the touch for 2 weeks. Right arm pit feels a little different than left based on self examination.
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| 46 | 2021-05-09 | peripheral swelling | After two days, my arm began to swell, itch, turned red and felt hot to the touch. |
| 46 | 2021-05-11 | peripheral swelling, lymph node swelling |
Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a ...
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Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a lemon) and swelling of right (minimal) closing throat, inability to swallow and challenge to breathe, tingling in hands, 90% loss of muscle strength in legs, heart palpitations (over 90 bpm - avg. 62), loss of concentration and low Co2, and flushed/redness in skin on neck, face, hands, back. I had many witnesses and 2 called 911 thinking it was anaphylactic shock with continuous throat swelling. Paramedic said that it did not appear to be an allergic reaction but could clearly see my lymph nodes swelling. Provided oxygen, Benadryl, IV and blood tests. No infection was found and no food allergy in past. I could not move my legs for a couple of hours but eventually had swelling, muscle strength decrease and return back to normal by the end of the evening. My first dose had no symptoms. However, I placed my hormone patch on the same arm of the second vaccine that week (*note -have used for over a year with no adverse reactions). Possibility of lymph node overdrive or anaphylactic shock with the combo? Should be looked into. Very serious, life threatening event.
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| 46 | 2021-05-18 | anaphylactic reaction |
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations...
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anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.
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| 46 | 2021-05-18 | swelling face |
Facial swelling noted an hour and half after shot.; This is a spontaneous report from a contactable ...
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Facial swelling noted an hour and half after shot.; This is a spontaneous report from a contactable consumer (reporting herself). A 46 year old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E87534), via an unspecified route of administration in right arm on 20Mar2021 at 14:00 as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks of COVID vaccination. The patient not diagnosed with COVID prior vaccination. The patient did not tested for COVID post vaccination. The patient was allergic to seafood (shellfish), antibiotics. The patient's medical history were not reported. The concomitant medication included collagen and peptide.On 20Mar2021 at 15:30, the patient experienced facial swelling noted an hour and half after shot. The patient received Benadryl as the treatment medication for the event. The outcome of event was recovering. Follow-up attempts are required. Further information was expected.
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| 46 | 2021-05-19 | peripheral swelling |
caller states it has worsened.; swelling and pain near arm pit; swelling and pain near arm pit; This...
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caller states it has worsened.; swelling and pain near arm pit; swelling and pain near arm pit; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 11:29 (Batch/Lot Number: EW0153, vaccinated at the age of 46 years old) as single dose for covid-19 immunisation. The patient received the first dose on 13Apr2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swelling near her arm pit, under the arm. It was pain and swelling and the patient thought it was near a duct or lymph node, but wasn't sure. The caller states that the patient had that vaccine on Tuesday and this is Thursday. Swelling started yesterday but he not sure on that. It is ongoing and that the caller states it has worsened. Outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of peripheral swelling and axillary pain and of the suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-03 | swelling face |
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m...
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12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
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| 47 | 2021-01-03 | swelling | EE presented to EH with c/o hives to face and racing heart rate at 1445 |
| 47 | 2021-01-04 | peripheral swelling |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-05 | white blood cell count increased |
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w...
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Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
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| 47 | 2021-01-06 | swollen extremities |
Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous repor...
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Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization. Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported. The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-06 | peripheral swelling |
Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive ...
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Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.
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| 47 | 2021-01-06 | swelling |
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a...
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Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
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| 47 | 2021-01-06 | swelling | SkinRash swelling Narrative: |
| 47 | 2021-01-07 | lymph node swelling, lymph node pain |
Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at ly...
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Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at lymph node site.
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| 47 | 2021-01-07 | lymph node swelling |
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is...
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swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-01-10 | lymph node swelling | Axillary lymphadenopathy, severe fatigue for two days |
| 47 | 2021-01-10 | lymph node swelling |
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o...
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vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
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| 47 | 2021-01-10 | oral herpes |
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume...
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ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
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| 47 | 2021-01-11 | anaphylactic reaction |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | lymph node swelling |
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t...
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Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
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| 47 | 2021-01-11 | peripheral swelling |
Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine...
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Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine with complaints of itching, burning feeling on skin and swelling in left arm. Red rash on chest and left arm. No sob, chest pain or difficulty swallowing. Ambulated to emergency room for evaluation.
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| 47 | 2021-01-11 | swelling face, peripheral swelling |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-12 | peripheral swelling |
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down...
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approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
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| 47 | 2021-01-12 | swelling |
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my ...
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Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
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| 47 | 2021-01-13 | lymph node swelling, axillary mass |
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and...
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12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
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| 47 | 2021-01-13 | lymph node swelling |
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE...
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THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
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| 47 | 2021-01-13 | peripheral swelling |
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of...
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intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
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| 47 | 2021-01-13 | swelling |
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the...
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Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
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| 47 | 2021-01-14 | lymph node swelling, lymph node pain | enlarged tender post cervical LNs on the left side, the same side where vaccine given |
| 47 | 2021-01-14 | swelling |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-15 | lymph node pain, lymph node swelling |
Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not...
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Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not responsive to Tylenol or ibuprofen. On day two fever that got as high as 101 degrees was observed. Severe headaches lasted from 4 hours after second injection until 48 hours after second injection. Beginning at about 48 hours post second injection painful tender lymphadenopathy observed in axillary area of left arm. I am now 96 hours post second injection and the lymph nodes in that left arm are still swollen and tender and painful.
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| 47 | 2021-01-15 | peripheral swelling |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-16 | lymph node swelling |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-17 | lymph node swelling |
Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and count...
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Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and counting
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| 47 | 2021-01-17 | swelling, swelling face |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-18 | lymph node swelling |
Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after in...
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Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after injection swelled. within a few hours unable to turn head without pain. From base of head to back was so sore and for 24 hours hard to turn head..
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| 47 | 2021-01-18 | peripheral swelling, swelling face |
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi...
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Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
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| 47 | 2021-01-20 | lymph node swelling |
she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints...
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she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints all over yesterday; had achy joints all over yesterday, saying her neck hurt; felt sick with a runny nose; felt sick with a runny nose; the gland in her armpit (clarified as left armpit) area is swollen and very painful; the gland in her armpit (clarified as left armpit) area is swollen and very painful; hard time sleeping.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 11:50 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin rash. There were no concomitant medications. The patient previously took diflucan 15 years ago and experienced extreme allergic reaction to diflucan; and amoxicillin and experienced rash. She stated she had a rash in the past to Amoxicillin and Penicillin. She received the COVID-19 vaccine on Saturday (09Jan2021), and the gland in her armpit (clarified as left armpit) area was swollen and very painful. She said she took Tylenol, and the Tylenol cut the pain. She stated she still has a little pain today. Her left armpit started feeling uncomfortable on Saturday night, and she had a hard time sleeping. She said when she woke up on Sunday morning, 10Jan2021, her left armpit area was extremely painful, clarifying she had left arm pain as well. She said the pain in her left arm has lessened today, but her left armpit area was still painful. Clarified she took a repeated 3 Tylenol 200 mg (600mg) dose over the past couple days for her left armpit pain. She took her first dose of 3 Tylenol 200mg tablets (600mg dose) at noon on Saturday, 09Jan2021, and another 3 Tylenol 200mg (600mg dose) at 5:00PM on Saturday evening and went to sleep. She said she woke up after her nap on Saturday evening, and was sweaty and had left armpit pain. She said she took another 3 Tylenol 200mg tablets (600mg dose) on Sunday, 10Jan2021, at 5:00PM. She said she took her last dose of 3 Tylenol 200mg tablets (600mg dose) this morning, 11Jan2021, at 7:00AM. On Saturday night, 09Jan2021, it was only her left armpit that was sore, but by Sunday, 10Jan2021 morning, her whole left arm was in pain and the gland in her left armpit was swollen. On 10Jan2021, the patient was very sweaty, and had a migraine. Clarified she felt sweaty now, like she just woke up from a fever. She said she was not overdressed, but maybe she was in a hot environment. She said she had no fever when she checked her temperature. She also had achy joints all over and her neck hurt on 10Jan2021. Patient reported that she had a PPD skin test administered 2 months ago and had no reaction to the PPD skin test. She felt sick with a runny nose on 10Jan2021, but she felt fine today, 11Jan2021. She said that after she received the COVID-19 vaccine, it was less than 24 hours when everything started happening. The patient had no history of all previous immunization with the Pfizer vaccine and no vaccines administered on the same date of the vaccine. The patient had no prior vaccinations within 4 weeks. Outcome of event hard time sleeping was unknown; she had left arm pain as well, had achy joints all over yesterday, saying her neck hurt, felt sick with a runny nose, was recovering; had a migraine yesterday was recovered on an unspecified date; and outcome of the rest of events was not recovered.
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| 47 | 2021-01-20 | lymph node swelling | Swollen painful lymph nodes (3) left axillary, tylenol/ibuprofen |
| 47 | 2021-01-20 | swelling face, swelling |
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f...
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10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
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| 47 | 2021-01-21 | axillary mass | DOLOR EN AMBOS AXILAS Y EL CUERPO. PRESENTA HEMATOMAS EN AREA DE AXILAS EN AMBOS BRAZOS. |
| 47 | 2021-01-21 | lymph node swelling, swelling |
vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe j...
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vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe joint pain, muscle aches and my left arm pit was painful, swollen lymph node in my left arm pit and left neck. Fever and joint pain were gone by sunday. Then on monday night I came down with a bad chest cold, runny nose and cough and chills but no fever. Chest cold symptoms still present today 1/22/21.
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| 47 | 2021-01-21 | lymph node swelling |
48 hours after vaccine developed Left axillary lymph node swelling and pain. Currently taking alleve...
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48 hours after vaccine developed Left axillary lymph node swelling and pain. Currently taking alleve for pain.
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| 47 | 2021-01-21 | lymph node swelling |
On 1/21/2021 I woke up and felt a large lump by on left clavicle. It was about 1.5inch, tender, war...
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On 1/21/2021 I woke up and felt a large lump by on left clavicle. It was about 1.5inch, tender, warm, smooth. I also had increased used of my albuterol inhaler due to shortness of breath. I went to the doctors. The started me on spariva and did a chest X-ray. They felt the lump was a swollen lymph node and to come back in two weeks if it remains swollen.
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| 47 | 2021-01-24 | lymph node swelling | Extreme body aches, swollen axillary lymph nodes of side of vaccine |
| 47 | 2021-01-24 | lymph node swelling | Soreness and swelling of underarm. |
| 47 | 2021-01-24 | lymph node swelling |
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontane...
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Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 47 | 2021-01-24 | peripheral swelling |
Headache, joint ache, fever, left deltoid swelling and left underarm/armpit swelling (size of half o...
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Headache, joint ache, fever, left deltoid swelling and left underarm/armpit swelling (size of half of a tennis ball)
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| 47 | 2021-01-24 | peripheral swelling | Fever Body Aches left underarm pain, and swollen |
| 47 | 2021-01-24 | swelling face |
Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight head...
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Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight headache
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| 47 | 2021-01-24 | swelling face |
Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per p...
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Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per patient.
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| 47 | 2021-01-25 | peripheral swelling, swelling, lymph node swelling |
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa...
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Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
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| 47 | 2021-01-26 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 47 | 2021-01-26 | lymph node swelling |
Approximately baseball-sized area of left axillary lymphedema. Edema and subsequent pain was first ...
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Approximately baseball-sized area of left axillary lymphedema. Edema and subsequent pain was first noticed just under 24 hours after vaccine dose and was completely resolved by the 5th day following the vaccination.
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| 47 | 2021-01-26 | lymph node swelling |
When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left...
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When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left side; This is a spontaneous report from a contactable nurse. This 47-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EK5730) at single dose in the left upper arm for vaccination on 21Dec2020. Relevant history included Hypertension. Relevant concomitant drug included Lisinopril 10 mg daily for blood pressure, Omeprazole 20 mg daily, Vitamin Supplements. The nurse stated, " When I got my first dose of vaccine I did have a swollen lymph node along my collar bone on the left side which is on the side where I got the shot and it didn't really change much. It just kind of stayed the same size and it remained there for whole three weeks. This small one along my collar bone that started right after the first vaccine and that has stayed the whole time. But got bigger after my second." No treatment was received. The outcome of event was not resolved. The patient believed the swollen lymph nodes were due to the Covid 19 Vaccine.
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| 47 | 2021-01-27 | lymph node swelling |
Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours...
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Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours after vaccine. Swollen and painful armpit node started 1 day after vaccine.
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| 47 | 2021-01-27 | swollen extremities |
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple h...
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Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
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| 47 | 2021-01-28 | lymph node pain, lymph node swelling |
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decr...
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Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
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| 47 | 2021-01-31 | peripheral swelling |
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, ...
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Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue 1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
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| 47 | 2021-01-31 | swelling face | I developed a lump under my cheeck and some facial swelling. |
| 47 | 2021-01-31 | swelling face |
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ...
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Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
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| 47 | 2021-02-01 | lymph node swelling |
12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Aroun...
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12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Around 8 hours after, I felt SOB and rash spread to all extremities. I took hydrosteroids; prednisode and benadryl. The rash started to get better about 4 hours later. 12/29 Body aches, fatigue. Swollen lymphnodes for at least 5-6 days. History of Severe allergies; eggs, shellfish, sulfa, etc. (listed on first page). Carry epi pen 24/7. Have not had Anaphylaxis reaction for 4 years. *premedicated with benadryl before 2nd vaccine. No rash. but still had body aches.
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| 47 | 2021-02-02 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 47 | 2021-02-02 | oral herpes |
fever, chills, headache from 12 hours post-vaccination through 36 hours. Full recovery after with sl...
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fever, chills, headache from 12 hours post-vaccination through 36 hours. Full recovery after with slight lingering headache and cold sore.
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| 47 | 2021-02-03 | lymph node pain, lymph node swelling |
Severe headache for 24 hours and off and on for a few days along with fatigue. Lymph nodes under ri...
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Severe headache for 24 hours and off and on for a few days along with fatigue. Lymph nodes under right arm swelled up 2 days after injection and remained swollen and painful for several day.
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| 47 | 2021-02-03 | lymph node swelling | Nausea, body aches, chills, swollen glands, sore arm. |
| 47 | 2021-02-03 | lymph node swelling |
swollen supraclavicular lymph nodes/axillary lymph node swelling; first dose of BNT162B2; on 26Dec20...
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swollen supraclavicular lymph nodes/axillary lymph node swelling; first dose of BNT162B2; on 26Dec2020 11:00 AM/second dose of BNT162B2; on 14Jan2021 11:00 AM; This is a spontaneous report from a contactable Nurse (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the left arm on 14Jan2021 11:00 AM at single dose for Covid-19 immunization in a hospital. Medical history was not reported. The patient has no COVID prior vaccination. The patient was not pregnant. Concomitant medications was none. The patient previously took vancomycin and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular at the left arm on 26Dec2020 11:00 AM at single dose for Covid-19 immunization. The patient has no other vaccine in four weeks. On 15Jan2021 11:00 AM, the patient experienced swollen supraclavicular lymph nodes approximately 24 hours after 2nd shot, some very minor axillary lymph node swelling both on left side, shot arm. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the event. The event swollen supraclavicular lymph nodes/axillary lymph node swelling was recovering. Follow-up activities are possible, information on the batch number has been requested.
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| 47 | 2021-02-03 | peripheral swelling |
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and ...
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Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
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| 47 | 2021-02-03 | peripheral swelling |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | swelling |
Starting at about 10 hrs last injection through 36hrs ran a low grade fever, chills, body aches, exh...
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Starting at about 10 hrs last injection through 36hrs ran a low grade fever, chills, body aches, exhaustion. At around hour 36 I noticed my right armpit hurting and visibly swollen
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| 47 | 2021-02-05 | lymph node swelling | REACTIVE LYMPH NODE SUPRACLAVICULAR |
| 47 | 2021-02-05 | lymph node swelling | Axillary lymph node under right arm swollen to the size of a cue ball |
| 47 | 2021-02-05 | swollen extremities, peripheral swelling |
12 hours after second injection, localized swelling and edema of right arm and shoulder extending to...
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12 hours after second injection, localized swelling and edema of right arm and shoulder extending to right ribcage. Fourteen hours post-injection (2nd dose only)Fever of 103.5, myalgia, chills, stiff neck, sheadache, and significant sharp pain in joints, muscle cramping in legs and arms. After treating with 600 mg ibuprofren, fever was reduced to 101.0. Fever recurred four hours later with profuse sweating. 600 mg of ibuprofren taken which again reduced fever to 99.8. At 24 hours post injection, swelling of ribcage and shoulder is subsiding, fever of 99.9. Having survived septic shock in 2011, I can say this felt the same. It was extremely painful.
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| 47 | 2021-02-06 | anaphylactic reaction |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-07 | swollen extremities |
Initial symptoms were sore throat and nausea the evening of the vaccination (Wednesday, 2/3/21). Th...
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Initial symptoms were sore throat and nausea the evening of the vaccination (Wednesday, 2/3/21). Those continued the following day and as the day progressed I also was experiencing a headache, mild achiness, left side of my neck was sore/tender, and then that evening chills and a fever of 101.3. On Friday, 2/5/21 I woke up with a very sore and swollen right axilla and still had a headache, but the fever resolved over night. All symptoms, except right axillary swelling/soreness was resolved by the afternoon on 2/6/21. Currently, on 2/8/21, I still have mild tenderness/soreness in right axilla.
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| 47 | 2021-02-09 | lymph node swelling |
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas...
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Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
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| 47 | 2021-02-09 | lymph node swelling |
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swol...
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Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
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| 47 | 2021-02-10 | swelling | Angioedema the following morning [ my lips were swollen +3] . No treatment sought . |
| 47 | 2021-02-10 | swelling face, swelling |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-13 | lymph node swelling |
After very little reaction on the day of besides some weakness and fatigue. The next evening I devel...
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After very little reaction on the day of besides some weakness and fatigue. The next evening I developed a swollen supraclavicular lymph node on the right side (same side as injection site) It became hard and painful.
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| 47 | 2021-02-14 | lymph node pain, lymph node swelling |
lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, l...
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lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, large lump in breast, red streaks. Pain in groin and shoulder, all on left side.
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| 47 | 2021-02-14 | lymph node pain, lymph node swelling | Swollen lymph node near the collar bone on the left side. Tender to the touch |
| 47 | 2021-02-14 | lymph node swelling |
Severe enlarged lymph node, resolved in about a week, large lump in armpit that was super sore and h...
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Severe enlarged lymph node, resolved in about a week, large lump in armpit that was super sore and hurt to the touch. Right arm pit.
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| 47 | 2021-02-14 | lymph node swelling |
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours...
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syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-15 | swelling face, swollen extremities |
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ...
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With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
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| 47 | 2021-02-16 | lymph node pain, lymph node swelling |
Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I...
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Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I looked in the mirror, to find a moderately large swelling. It increased in size overnight Sat. Feb. 13. Sunday, the swelling reduced a bit, to the same size I found it originally. It has remained that size - a decent golf ball - since then, Sun. Feb., 13. Though localized tenderness in lymph nodes has decreased quite a bit, I'm now in a significant Fibromyalgia flare (which could also be explained by a change in weather).
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| 47 | 2021-02-17 | lymph node swelling | Left axillary lymph node swollen . Sleep paralysis. Tired. Dizzy, hungry thirsty. |
| 47 | 2021-02-17 | peripheral swelling |
I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the inject...
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I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the injection - red on outside. Whole arm was red and swollen. That lasted several days. Next day after vaccine, Inside of my arm, I noticed rash (looked like chicken pox/mosquito bites) and then it went to chest, abdomen and legs. The rash continued. My face was flushed and had a 99.9 fever. I had foggy brain and chest pain (started day after the vaccine). The chest pain would last about a minute - I monitored my heart rate. From sitting down my heart rate when up to 120 and down to 37. This occurred for four days - four - six times a day. By the 3rd day after vaccine, I started feeling worse. I experienced dizziness, nausea, couldn't think, was disorientated, rash on my body, no appetite, couldn't sleep well and had no energy and chest pain - was in bed for next three days. I didn't call my Dr right away, I was monitoring the chest pain while I rested. That resolved (chest pains) by Saturday. The rest continued. My Monday, I called Public Health and they advised to call my DR. Spoke to Dr. on 11th. On the 12th, I had a telehealth appt with him. On the 13th had an EKG done. Everything normal on EKG. I continued feeling dizzy and no energy. I didn't work until Jan 19th. On the 20th, I felt foggy brain and rash wasn't gone and I went back to my doctor on January 21 and he put me off work for another week. At this point, within the last few days, my energy is back and rash is gone - I do still have dark spots on back and legs from the rash. On January 25th, I got the second dose. (The rash kind of flared back after second dose but nothing as bad.)
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| 47 | 2021-02-17 | swelling face, lymph node swelling |
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, g...
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My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
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| 47 | 2021-02-18 | swelling |
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4...
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After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
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| 47 | 2021-02-18 | lymph node swelling | Symptoms: Headache, Nausea, Fever, Aches, Chills, Ear pain, Swollen glands, Fatigue |
| 47 | 2021-02-18 | oral herpes |
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15...
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Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine. On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
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| 47 | 2021-02-19 | swelling face | my face swollen and painful |
| 47 | 2021-02-22 | swollen extremities | Swelling underneath arm pit. doctor advised Tylenol and warm compress |
| 47 | 2021-02-22 | swelling face |
Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continue...
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Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continued with bumps and itchiness. Went to Urgent Care on February 20th and started steroids. The swelling increases while I am sleeping.
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| 47 | 2021-02-23 | lymph node swelling |
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli...
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Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 47 | 2021-02-28 | lymph node swelling |
After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt...
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After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt like it was ripping out of my left arm and it was tender. The lymph node subsided after two days of the vaccination. I also had two menstrual cycles back to back which was out of the ordinary for me since I am regular on my periods. I saw my gynecologist due to my menstrual symptoms. I was regular up to that point of my vaccination. One week ago I had better range of motion to my left arm.
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| 47 | 2021-03-01 | lymph node swelling, lymph node pain | Right groin lymph nodes swollen and painful. |
| 47 | 2021-03-01 | lymph node swelling |
Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Profe...
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Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El3264), intramuscularly on 28Jan2021 at 15:45 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), on 07Jan2021at 16:40 in the left arm for COVID-19 immunization. The paktient has unspecified allergies to Penicillin. The patient previously too clindamycin (UNKNOWN MANUFACTURER) and experienced an unspecified allergy.The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications were not provided. On 28Jan2021 at 19:15, the patient experienced a swollen lymph node in the left arm. The patient did not receive any treatment for the event. The clinical outcome of swollen lymph node was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-03-02 | lymph node swelling |
I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first ...
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I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first dose 3 weeks prior was in my right arm. I did not experience any side effects from the shot for 4 days. I woke up on Tuesday, February 23rd and had pain in my right arm - the arm I had the 1st shot in, not the 2nd! I continued to have pain in my right arm for several days and then 6 days after my 2nd dose I started having extreme pain in my legs - from my knees up the back of my thighs for two days. Then 8 days after my 2nd dose my other arm became very sore, the arm I had the 2nd dose in. So both arms are sore and the lymph nodes under the arms are tender. Today I am 11 days out since my 2nd dose and I woke up and could barely lift my left arm. I have pain in both arms and lymph nodes. I went to my family doctor and he does not have any answers for me. I need to know if this is something I should be concerned about and if there is anything I can do to help these side effects go away. How long can this last???
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| 47 | 2021-03-03 | anaphylactic reaction |
Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and h...
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Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and had increasing mucous. Pt stated this is how she feels when she has an anaphylactic reaction. HR was 122 and B/P 155/93. Benadryl 50 mg given at 0930, and epi given at 1001. Solumedrol at 1032 O2 99% at 1034. ACLS transfer to ER.
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| 47 | 2021-03-04 | lymph node swelling |
Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphn...
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Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphnodes, general malaise. By Friday night, developed a hive below her lips and her left arm was 'itching" severely. Took benadryl again. Didn't have problems Sunday night. Today arm started itching a lot throughout the day. About 45 minutes ago, experienced redness and hives again, a 1 inch by 4inch welt. Pt also states she has multiple conditions that have cause allergic reactions. Son has Mast Cell Activation symptom Disposition: ER. Concern for allergic reaction.
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| 47 | 2021-03-04 | swelling face |
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ...
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The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
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| 47 | 2021-03-04 | swelling |
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s...
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Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 47 | 2021-03-06 | swelling, lymph node swelling, swelling face |
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ...
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Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
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| 47 | 2021-03-07 | lymph node swelling | Swollen lymph node in left armpit. |
| 47 | 2021-03-09 | swelling |
Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (pat...
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Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2 (brand= Pfizer Biontech), lot no. EL3248, via an unspecified route of administration (right arm) on 05Feb2021 15:00 at a single dose for COVID-19 immunization at a pharmacy or drug store. The patient had no relevant medical history. No known allergies. No COVID prior to vaccination. Concomitant medications included levothyroxine sodium and escitalopram. No other vaccine in four weeks. The patient experienced large swollen spot in her right armpit on 06Feb2021 16:00. No treatment received for the event. No COVID test post vaccination. The outcome of the event was not recovered.
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| 47 | 2021-03-09 | swelling |
swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Tre...
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swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Treatment- took Benadryl orally and topical Outcome- swelling and itchiness still exists
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| 47 | 2021-03-11 | peripheral swelling |
Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at ...
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Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at 5 PM slept the rest of the day through 11 AM . Arm still swollen and red hot to the touch have put ice on it still getting bigger, tightness in chest and short of breath 2 days later , seen my dr she stated it is an allergic reaction and she recommended I do not get the second dose since this one has made me sick.
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| 47 | 2021-03-13 | lymph node swelling | Chills, difficulty with breathing, tiredness, fever, swollen lymph nodes, and headache. |
| 47 | 2021-03-14 | lymph node swelling |
The night of the first dose, patient presented joint pain, stiffness and high temperature for 24 hou...
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The night of the first dose, patient presented joint pain, stiffness and high temperature for 24 hours. On the second dose, immediately had nauseas and vomiting. It felt like Hyperemesis gravidarum symptoms and high temperature for 36 hours. Pain and stiffness on the joints. Also swelling of the lymphatics under the left arm about size of a softball. Tiredness and felt sleepy for approximately one week.
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| 47 | 2021-03-14 | lymph node swelling | Swollen lymph node, headache, extremely tired & runny nose. |
| 47 | 2021-03-15 | swelling face |
"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pr...
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"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pressure, headache, and swelling of the eyes/face. These symptoms began a few hours after the shot and subsided by Tuesday. I used over the counter medication to treat the symptoms. It was not severe enough for me to feel the need to seek additional medical care. If it had worsened, I would have gone to the doctor"--copied from pt email
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| 47 | 2021-03-15 | swelling, swelling face |
Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but f...
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Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but felt face tingling similar to hyperventilating. ER visit identified normal o2 and provided allergic reaction treatment of benadryl pills and prednisone injection right arm.
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| 47 | 2021-03-16 | anaphylactic reaction |
47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covi...
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47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine. Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation. In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid. Patient has history of anxiety and jittery as well as nervousness after epinephrine. Patient was then given 1 mg p.o. Ativan for her symptom. On my evaluation, patient is not in respiratory distress, She is still Tachycardic in the 110s-120s Which is likely from the EpiPen. Patient stated that she normally stays tachycardic for a while after the epipen. Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling. Patient also has no wheezing on auscultation exam. We discussed the possibility of staying in the hospital under observation versus going home. Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
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| 47 | 2021-03-16 | peripheral swelling, swelling face |
This is a follow up report starting from day after that first report was made -Report # 244159 - Sta...
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This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
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| 47 | 2021-03-16 | swelling face |
I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscl...
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I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscle aches in my left leg and my left arm and leg felt heavy. During the night, I got extreme night sweats but ONLY on the left side of my body. Right side was dry. The next day I got a headache on the left side of my head only, the left side of my face was hot and right side was cool, aches in my left leg arm, neck, and shoulder. Then my left side of my face became numb and swollen. The numbness on the left side of my face got a little better every day but lasted for a week and even 2 weeks later it feels a bit tighter than the right side. I am supposed to get the 2nd shot in a week, and I do not believe I should but really need to talk to someone about this. No one is returning my messages and I have emailed VAERS.. please help.
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| 47 | 2021-03-16 | swelling | Swelling red blotches burning feeling wierd shape tierd |
| 47 | 2021-03-17 | axillary mass |
I received the vaccine in my left arm and shortly thereafter suffered a medium sized, painful lump i...
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I received the vaccine in my left arm and shortly thereafter suffered a medium sized, painful lump in my left armpit. So far its lated 4 days and occurred on the side where axillary Lymph nodes have not been removed.
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| 47 | 2021-03-18 | lymph node swelling |
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry...
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Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
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| 47 | 2021-03-19 | lymph node swelling |
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at ...
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I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr. I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis. After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in acute pain.
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| 47 | 2021-03-19 | lymph node swelling | Fever Chills Nausea Swollen lymph nodes on clavicle and under arms |
| 47 | 2021-03-19 | swelling |
20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, an...
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20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, and headache. The patient did not report trouble breathing. Patient was given 600 mg ibuprofen and 50 mg diphenhydramine
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| 47 | 2021-03-20 | anaphylactic reaction |
Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and to...
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Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.
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| 47 | 2021-03-21 | lymph node swelling |
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body ac...
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1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea, and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over. My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
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| 47 | 2021-03-21 | lymph node swelling |
7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as in...
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7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as injection. Swelling was red and painful. (I also became very sick after 2nd injection and was in bed for 2 days... had sweats, nausea, chills and brain was foggy.)
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| 47 | 2021-03-22 | lymph node swelling |
When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of ...
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When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of and the next day. I began having swollen lymph nodes 2 days after the injection and weakness in the upper arm and elbow area. I cannot lift my arm without discomfort.
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| 47 | 2021-03-22 | lymph node swelling |
sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swo...
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sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swollen lymph note on right side (shot on the left) so tired, no appetite
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| 47 | 2021-03-22 | swelling face |
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as...
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10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
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| 47 | 2021-03-23 | lymph node swelling | Swollen Lymph Node in Clavicle |
| 47 | 2021-03-23 | oral herpes |
Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt ...
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Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt itchy and then immediately afterward a very painful and swollen further inside. That was Friday night. for the remainder of the weekend I had terribly painful urination. I called my OB/GYN and scheduled an appointment for January 19. I prescribed Valtrex for possible herpes and Ciprofloxacin for possible bladder infection. The results came back as Oral herpes that were in my vagina. I would like to add that I did have a strong immune response to the second covid vaccine and had muscle aches, chills and malaise.
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| 47 | 2021-03-23 | peripheral swelling |
at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At ...
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at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At 30 min past the vaccine the vaccine center gave me 25 mg of benadryl and had me follow up with an urgent care center. I went home and took hydrozine because I continued to have hives and a rash, I could not afford to seek emergency help at the urgent care center and stated that to the vaccine center. The vaccine center said because I was able to breathe they could not transport me to the emergency room or urgent care center.
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| 47 | 2021-03-23 | swelling face |
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ...
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After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
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| 47 | 2021-03-25 | lymph node swelling | Axillary lymphadenopathy on left side |
| 47 | 2021-03-25 | swelling, peripheral swelling, lymph node swelling |
Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axilla...
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Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axillary lymph nodes, redness, and difficulty moving arm. Redness was in an area over right deltoid approximately 4in vertically X 3 in horizontally. Redness did not go into shoulder, but started approximately 2 finger breaths below shoulder. Appeared vaccination was given in proper location. Client stated she was taking .Motrin and using the arm very frequently. She was tearful when moving arm. Client feels her pain threshold is high due to hx of broken hip in past and this pain seems worse. Client was very concerned about a worse reaction with a second vaccine. Client did state, " the nurse said I was a really small person so she was going to use a smaller needle." This nurse believes that means nurse at mass vaccination clinic used a 5/8 in needle. Client probably weighs 120-130lbs. Client did not and did not want to sign up for Vsafe. After discussion client decided to go to Urgent Care. Follow-up phone call to client at 12:30pm on 3/26. Client states Urgent Care Dr did not think it was cellulitis. Client was very fatigued and stated she then went to daughters and took 2 hour nap. She felt she did not want to go home by self as she was still very concerned. Client states, 'has hx of developing significant tongue swelling throat closing reaction to Bactrim about 4 days after starting and physician telling her in the ER she could have died if she did not come in'. Advised her to get 2nd vaccine. Client is still undecided about getting 2nd vaccine. Pain has decreased, but arm remains swollen and is now itchy. Client will continue to monitor and return to urgent care if symptoms get worse.
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| 47 | 2021-03-26 | swelling, swelling face |
12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was mov...
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12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was moved to a private location and EMS began assessment. aprox 12:40pm EMS called for transport to a medical facility - the patient experienced vomiting, neck swelling, facial swelling and inability to speak - IV access was obtained by EMS and Benadryl was given IV - she was then given another IM injection of Epi by the EMS team she agreed to transport and was then transported to the hospital around 1:30pm
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| 47 | 2021-03-28 | peripheral swelling |
Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observe...
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Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observed for 30 minutes due to my prior anaphylactic reaction to a wasp sting. 40 minutes after injection, 10 minutes after leaving the pharmacy, I developed a welt-sized hive on my left foot. It was gone by the time I returned home. I then had hives on my left forearm. They went away with out treatment. At thas point, I had itching and swelling of the thumb on my left hand. That was somewhat painful. That was also the location of my wasp sting in July 2020. That also disappeared without any treatment from my of oinment or benadryl. I then found hives on my waist and stomach while lastly experiencing swelling on my lip. Again, this was all methodical almost over the course of 5-6 hours after injection. One hive would go away to have hives appear in another location. At 9pm that evening, I experienced sudden lower back pain on the right side and had difficulty walking due to the pain resulting from weight being placed on that side. My research suggested it was sciatica. I have no history of sciatica other than some discomfort during my pregnancies, the last of which was nine years ago. I treated this with 8oomg of ibuprofen and went to bed. Several hours later, I was awoken by the right leg shaking in my sleep. It was like a significant tremor. It stopped within a few minutes of me waking up. I was able to go back to sleep. However, I continued to experience sciatic pain on Sunday, March 28th and a bit today, March 29th. It has dissipated significantly and I am not functional. There was no repetition of the leg tremor after the initial and sole incident. I continued to have sporadic hives on my upper body on Sunday, March 28th. There are none present today, March 29th.
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| 47 | 2021-03-29 | anaphylactic reaction | Anaphalactic |
| 47 | 2021-03-29 | peripheral swelling |
Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a co...
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Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 25Feb2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies and food sensitivities. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR) and lansoprazole (PREVACID); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 via nasal swab COVID-19 on 08Jul2020 with negative result and on 07Jan2021 with unknown results. The patient experienced pressure on chest, respiratory allergies and swollen right hand on 26Feb2021 at 10:30 PM. The patient was treated with diphenhydramine hcl (BENEDRYL) for the events, pressure on chest, respiratory allergies and swollen right hand. The outcome of events, pressure on chest, respiratory allergies and swollen right hand was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
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| 47 | 2021-03-30 | lymph node swelling | Swollen lymph nodes in left armpit. Could barely move arm. |
| 47 | 2021-03-30 | lymph node swelling |
1st dose my glands had some swelling; This is a spontaneous report from a contactable consumer (pati...
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1st dose my glands had some swelling; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in Arm Left on 06Jan2021 14:45 as single dose for covid-19 immunisation at Hospital. Medical history included, drug hypersensitivity (Allergies: Penicillin) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole sodium (NEXIUM) and ibuprofen. The patient previously took amoxicillin, codeine and experienced hypersensitivity. The patient reported 1st dose my glands had some swelling on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of 1st dose my glands had some swelling (lymphadenopathy). The outcome of event was recovered.
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| 47 | 2021-03-30 | peripheral swelling |
Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested posit...
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Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested positive for Covid/can't stop coughing/ like the whole kind of flu symptoms, body aches, arm hurt; Tested positive for Covid; Hives all over body and tested for Covid 2 days later; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:15 at single dose for covid-19 immunisation. Medical history was none. Allergies to medications, food, or other products was nope. Concomitant medications were not reported. The patient previously took dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 at single dose for covid-19 immunization. The patient experienced tested positive for covid on 07Mar2021 with outcome of unknown, hives all over body and tested for covid 2 days later on 06Mar2021 06:00 AM with outcome of recovering, can't stop coughing on an unspecified date with outcome of unknown, like the whole kind of flu symptoms on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, arm hurt on an unspecified date with outcome of unknown, little tired today/exhaustion on an unspecified date with outcome of recovering, chills on an unspecified date with outcome of unknown, legs look swollen on an unspecified date with outcome of unknown, itching everywhere on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021. She is not pregnant. She is not pregnant at the time of vaccination. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, Pcr, on 07Mar2021with result of Positive. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and test name was Pcr. The clinical course was reported as follows: Consumer stated, The other day, on Friday, I got my second dose of the Pfizer COVID-19 vaccine. And of course that's why I have like horrible symptoms, but since then I am covered in hives and it's really itchy. When paraphrased the concern, consumer stated, And then I just have a question, what happened was, we found out the same day, my son tested positive for COVID when I got the shot. And then like within 4 hours later of the shot, I can't stop coughing either. Means yesterday, I had like the whole kind of flu symptoms, body aches, arm hurt, you know, which are definitely going away. Little tired today but I still have the cough more in the throat and I am covered in hives. Consumer further stated, My husband and my other son were tested, they are negative. I am supposed to go today. Like I do not know what to do and I do not know what's going on but I am itching everywhere. Yesterday, I had like kind of the symptoms they said like body aches, like flu like symptoms, chills. I did not have a fever, just exhaustion and I did have hives yesterday but today I feel like my legs look swollen. I am itching everywhere and they are not away and I still have a 'cough like in ear through my throat' (not clarified). So, do you think should I still get tested today? Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, What should I do as I got the rash and everything. I would rather, I just need to get tested for the rash and the 'cough' (not clarified). Consumer stated, And they are going to give me information on these hives and everything? Inofrmation regarding lot/batch number has been requested.
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| 47 | 2021-03-30 | peripheral swelling |
swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spon...
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swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that ‘'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
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| 47 | 2021-04-01 | lymph node swelling |
after 1st dose of vaccine given in left arm, patient experience some arm soreness and noticed lump u...
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after 1st dose of vaccine given in left arm, patient experience some arm soreness and noticed lump under her left armpit with some swelling to area.
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| 47 | 2021-04-01 | peripheral swelling |
Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated ar...
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Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated arm down to hands/fingers. Swelling at injection site. Then started to feel hot/sweaty. Swelling occurred in bilateral arms and fingers and weakness in the legs. No breathing issues but then reported swelling of lips and tongue. Gave 50mg Benadryl. Called EMS with consent
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| 47 | 2021-04-01 | swelling |
Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vis...
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Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vision, at this point the pharmacy staff was alerted and the emergency kit was taken to the patient. The patient then started flushing and began swelling. Patient's vitals were normal but she continued to swell showing significant signs of allergic reaction. Patient was transported by ambulance to Hospital ER
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| 47 | 2021-04-04 | lymph node swelling | swollen lymph node armpit left arm (same arm injection) |
| 47 | 2021-04-09 | swelling face, peripheral swelling |
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a...
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About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
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| 47 | 2021-04-13 | white blood cell count increased |
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa...
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hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
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| 47 | 2021-04-15 | peripheral swelling |
Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/...
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Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/2021 my right leg began to swell terribly and then on 4/6/2021 it was discovered that I had one big and many small blood clots in my right leg.
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| 47 | 2021-04-26 | lymph node swelling |
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/...
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diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
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| 47 | 2021-04-27 | lymph node swelling, peripheral swelling |
Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 e...
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Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 evening and into day 2), Nausea (day 1 evening and into day 2), Headache (day 1 and into day 4), Chills (day 1 and into day 4), Red itchy rash causing swelling on top of wrists on both arms (started day 3 and still ongoing)
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| 47 | 2021-04-30 | swelling, lymph node swelling |
1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - ...
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1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints 2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
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| 47 | 2021-05-04 | swelling face |
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo...
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fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 47 | 2021-05-18 | swelling, anaphylactic reaction |
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling...
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Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.
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| 47 | 2021-05-19 | oral herpes |
diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the ...
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diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the roof of the mouth; large cold sore on lip and a canker sore on the roof of the mouth; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 16:30 (Batch/Lot Number: ER8731) at 47-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing (also reported as none and if COVID prior vaccination: No). The patient had no known allergies. There were no concomitant medications. On 13Apr2021 at 20:30, the patient experienced: large cold sore on lip and a canker sore on the roof of the mouth (non-serious). On 18Apr2021 at 09:00, the patient experienced: nausea (non-serious). On 05May2021, the patient was diagnosed with COVID (medically significant). The events, large cold sore on lip and a canker sore on the roof of the mouth and nausea, required a physician office visit; however, no therapeutic measures were received. The clinical course was reported as follows: Four hours after the injection, the patient developed a large cold sore on her lip and a canker sore on the roof of her mouth. On 18Apr2021 at 09:00 (also reported as five days later), the patient began experiencing nausea that she was still experiencing 18 days later. The patient was then diagnosed with COVID on 05May2021. The patient underwent lab tests and procedures which included Qualitative PCR (Nasal Swab): positive on 05May2021. The clinical outcome of the events: large cold sore on lip and a canker sore on the roof of the mouth and nausea, was not recovered. The clinical outcome of the event, diagnosed with COVID, was unknown.
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| 48 | 2021-01-01 | lymph node swelling |
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ...
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Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
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| 48 | 2021-01-03 | lymph node swelling, lymph node pain |
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen...
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Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
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| 48 | 2021-01-03 | swollen extremities, peripheral swelling |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-04 | anaphylactic reaction |
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em...
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Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
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| 48 | 2021-01-04 | lymph node swelling |
Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes...
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Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself). This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
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| 48 | 2021-01-04 | swollen extremities |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-05 | lymph node swelling, lymph node pain | Swelling and pain in right axillary lymph node. Started 1 week after vaccine |
| 48 | 2021-01-05 | swollen extremities, peripheral swelling |
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual wor...
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Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
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| 48 | 2021-01-05 | peripheral swelling |
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable...
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c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
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| 48 | 2021-01-05 | swelling face |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-06 | anaphylactic reaction |
anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report...
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anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-06 | lymph node pain |
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill...
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Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
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| 48 | 2021-01-06 | swelling face |
Pt reported right sided facial swelling (no numbness or tingling) after admin of 2nd COVID19 vacc...
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Pt reported right sided facial swelling (no numbness or tingling) after admin of 2nd COVID19 vaccine. Pt had been diagnosed with COVID19 on 12/27 between both vaccines. SHe denied any numbness, tingling, weakness, tongue swelling, lip swelling, dysphagia, wheezing or shortness of breath. no eyelid swelling. no rash.
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| 48 | 2021-01-07 | lymph node swelling |
Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she ...
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Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
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| 48 | 2021-01-07 | peripheral swelling |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-07 | swelling face |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-08 | lymph node pain |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-08 | peripheral swelling, swelling face |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-11 | lymph node swelling, lymph node pain |
Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, c...
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Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, chills, axillary lymph node tenderness and swelling, fever (Tmax 102.2). EE reports she called off of work Monday but later came to work later at approximately 09:00. EE reports Monday resolution of all symptoms except still worsening lymph node tenderness and swelling. EE reports she emailed Woodlands EH RN and advised to contact HR vaccine support line to notify of adverse reaction. EE report she filled out V-safe. Last day of work and shift - ?currently working today Home remedies? - rest and motrin (last dose at 8:30 PM on Sunday 1/10) Any improvement? ? EE reports resolution of all symptoms except lymph node swelling and tenderness Recommendation? EE encouraged to rotate Tylenol and motrin q3h and to contact PCP for appointment.
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| 48 | 2021-01-11 | lymph node swelling | L axillary lymph node swelling and pain ( shot was in L deltoid injection site_) |
| 48 | 2021-01-11 | swelling face | facial swelling, temporary loss of vision in one eye |
| 48 | 2021-01-11 | swelling |
January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck sw...
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January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck swelling noted with bounding pulse in jugular region x 9 days. Seen by physician Jan 5. Neck ultrasound performed Jan 11. Awaiting results.
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| 48 | 2021-01-12 | lymph node swelling | Painful Left supraclavicular lymphadenopathy |
| 48 | 2021-01-12 | lymph node swelling | Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla |
| 48 | 2021-01-12 | swollen extremities |
Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx....
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Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx. 1430, progressively worsened.
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| 48 | 2021-01-13 | anaphylactic reaction |
Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response T...
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Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response Team initiation and immediate transport to Emergency Room.
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| 48 | 2021-01-13 | lymph node swelling | FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS. |
| 48 | 2021-01-13 | swelling face |
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ...
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knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
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| 48 | 2021-01-13 | white blood cell count increased |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-14 | lymph node swelling |
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then...
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Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
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| 48 | 2021-01-14 | peripheral swelling |
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w...
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day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
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| 48 | 2021-01-14 | peripheral swelling |
Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She...
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Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020. Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
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| 48 | 2021-01-14 | swelling face |
face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat start...
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face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat started 24 hours after vaccine . Severe headache and joint pain started 27 hours after vaccine
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| 48 | 2021-01-17 | lymph node swelling |
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard....
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At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
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| 48 | 2021-01-17 | swelling face |
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an...
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On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
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| 48 | 2021-01-17 | swelling face | nausea, head ache, dizziness, SOB, face swelling a bit |
| 48 | 2021-01-17 | swelling face |
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la...
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I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
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| 48 | 2021-01-18 | lymph node swelling |
Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of t...
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Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of the vaccine, patient started with leg weakness and a sensation of "heaviness" and tremors. Received hydration at ER Room. But 2 days later, developed severe lymphadenopathy at axilla of the same arm (right) where received vaccine.
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| 48 | 2021-01-18 | peripheral swelling | ear congestion Bilateral hand swelling, redness BP 132/92 HR 107 P 70 99% RA |
| 48 | 2021-01-19 | anaphylactic reaction |
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than inj...
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Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
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| 48 | 2021-01-19 | anaphylactic reaction |
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl...
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Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
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| 48 | 2021-01-19 | lymph node swelling |
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node...
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injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
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| 48 | 2021-01-20 | lymph node swelling, lymph node pain | Enlarged supraclavicular lymph node with swelling and pain |
| 48 | 2021-01-20 | peripheral swelling |
48 hours post-injection thumb on opposite side of the injection became swollen and stiff. There was ...
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48 hours post-injection thumb on opposite side of the injection became swollen and stiff. There was no trauma to the thumb. No other joints are swollen or stiff. The joint is more swollen, stiff and painful 1 week later (1/20/21), leading to a video visit with PCP who recommended alternating heat and ice, and continued use of NSAID as needed.
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| 48 | 2021-01-21 | lymph node swelling, swollen extremities | Lymphadenopathy, right axilla - moderate swelling with pain. |
| 48 | 2021-01-22 | lymph node swelling | Fever 102.7 , chills, arm with axillary lymph node swelling. |
| 48 | 2021-01-23 | anaphylactic reaction |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | lymph node swelling, swelling, swollen extremities |
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe...
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23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
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| 48 | 2021-01-24 | peripheral swelling, lymph node swelling |
1/9/21 swollen left cervical and supraclavicular lymph nodes 1/12/21 blunt effusion left knee with s...
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1/9/21 swollen left cervical and supraclavicular lymph nodes 1/12/21 blunt effusion left knee with subsequent development of Baker's cyst, swollen bilateral axillary lymph nodes 1/25/21 worsening of left knee pain, swollen left calf
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| 48 | 2021-01-24 | peripheral swelling |
Vaccinated on 1/22/2021 around 0945. By 2100 that night, symptoms began to set in. No fever but fel...
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Vaccinated on 1/22/2021 around 0945. By 2100 that night, symptoms began to set in. No fever but felt febrile, body aches, joint pain, and "it felt like all my organs were under attack. I felt better Sunday morning', January 24th. After the 1st dose, arm swelled to elbow and had minor body aches but nothing too significan.
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| 48 | 2021-01-24 | sepsis |
Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a ...
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Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days. On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-01-25 | lymph node swelling |
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report...
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Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | swelling face, peripheral swelling |
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan...
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Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
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| 48 | 2021-01-25 | swelling |
neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding puls...
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neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding pulse (palpitations); This is a spontaneous report from a contactable consumer on behalf of herself. A 48-year-old female patient received her first BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EH9899, via an unspecified route of administration on 28Dec2020 at SINGLE DOSE at left upper arm for COVID-19 immunisation. There were no relevant medical histories or concomitant medications. The patient had a vaccination on 28Dec2020 and seven days later on 04Jan2021 her neck was mildly swollen and that same day it became more swollen and she had a bounding pulse also reported that had mild superficial neck swelling and a bounding pulse in her neck. The swelling has gone down, but got worse in the evening. The bounding pulse (palpitations) in her neck has improved but got worst at night, still occurred at night. No difficulty breathing and/or swallowing. She went to her physician on 05Jan2021 to find out why occurring. She was called to see if based off this symptom if she should have her second shot of vaccination. Followed up with her MD and had an Ultrasound (US) of her jugular in Jan2021 and all was normal. The outcome of the events was resolving.
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| 48 | 2021-01-26 | lymph node pain, lymph node swelling |
a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar b...
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a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
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| 48 | 2021-01-26 | lymph node swelling, swelling face, swelling |
swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling s...
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swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
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| 48 | 2021-01-26 | lymph node swelling |
Supraclavicular lymph node swelled to about pea size after 1st dose; This is a spontaneous report fr...
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Supraclavicular lymph node swelled to about pea size after 1st dose; This is a spontaneous report from a contactable Other-HCP. This 48-year-old female Other-HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at Left arm at single dose for COVID-19 immunization in Dec2020 06:00 AM. Relevant history included Known- allergies: Augmentin. Other medications in two weeks included sertraline 50mg, vitamin D3 5000 IU. The patient was not pregnant. The patient experienced supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose. The outcome of event was Recovered with lasting effects. No treatment was received. The patient was not diagnosed with covid-prior-vaccination. The patient did not have covid-tested-post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030973 Same patient same product, similar event, different event time gap
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| 48 | 2021-01-26 | lymph node swelling | Lymphadenopathy in left axilla |
| 48 | 2021-01-27 | axillary mass | Moderate lump to Breast/axilla area |
| 48 | 2021-01-27 | lymph node swelling, peripheral swelling |
Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turnin...
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Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turning red a size of a softball was extremely red swollen and hot to the touch, shoulder area and under arm pit was swollen and hurt to touch are move. Was informed by employee health to start taking antihistamines (which I already take) so she told me to increase the amount by taking Benadryl as well and icing it on and off for 30 minutes at a time, The people here at my work checked it regularly and slowly it is improving each day as long as I ice and take extra antihistamines.
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| 48 | 2021-01-27 | lymph node swelling |
Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swolle...
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Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swollen lymph nodes. The reaction occurred 7days after the first dose and the next day after the 2nd dose. While the armpit started to feel better before the 2nd dose I wouldn't say symptoms resolved before the 2nd shot.
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| 48 | 2021-01-27 | lymph node swelling |
Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up f...
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Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up for longer than 10-15 minutes at a time without leaning on desk or needing to lay down), general muscle pain (not as severe) throughout the rest of my body. Headache, fatigue (exhausted), brain fog, muscle tightness (unable to take a deep breath due to tightness...not short of breath). Swollen lymph nodes in right armpit, overall feeling exhausted. Treatment: I just slept a lot, took Tylenol. I have a doctors appointment today. Outcome: Slowly getting better. Still have brain fog , fatigue (not exhausted anymore), muscle weakness (not the severe pain anymore).
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| 48 | 2021-01-27 | swelling |
Pt developed redness and swelling to neck, along with lightheadedness several minutes after injectio...
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Pt developed redness and swelling to neck, along with lightheadedness several minutes after injection. BP, pulse, oxygen saturation and breath sounds were all within normal limits. She denied any dyspnea or difficulty swallowing. EMS was called promptly and pt was given Benadryl 50mg x1 while EMS was en route. Her symptoms remained stable and she was taken to the hospital by Rescue.
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| 48 | 2021-01-28 | oral herpes |
I have a cysts/lesion on the outside of my lip (I thought it was a pimple but it was so big and I ne...
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I have a cysts/lesion on the outside of my lip (I thought it was a pimple but it was so big and I never felt anything come on like I always do). I also have internal cold sores - one almost right on the other side of the lesion, one on the other side of my lip. I DO NOT KNOW IF THIS IS A SIDE EFFECT or just a coincidence. I don't have herpes or any history of lip lesions. I don't remember biting my inside lip and they are too high for that type of injury anyway.
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| 48 | 2021-01-28 | peripheral swelling |
FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN ME...
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FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN MEDICATION (TYLENOL AND IBUPROPHEN) HELPED RELEIVE ENOUGH OF THE PAIN. READ AND SWOLLEN FEET LOWER LEGS. UPPER BACK PAIN LINGERING. TOP OF HEAD PAIN, SCALP PAIN. SEVERITY OF PAIN HAS GONE AWAY, FOOT AND LEG ISSUES HAVE GONE AWAY. UPPER PART OF BODY AND HEAD STILL HURT.
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| 48 | 2021-01-29 | anaphylactic reaction |
After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 2...
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After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 20 minutes I also began to feel more light headed/dizzy. I was moved to be observed by a nurse for another 20 minutes and when symptoms did not subside I was moved to the Emergency Department where they administered Epinephrine at 9:27am, Pepcid, 9:24am, Solu-medrol 9:24-10:50am. Diagnosis: Anaphylaxis. Dr. wanted to prescribe Benadryl IV but I declined as I needed to drive home and the facility was far from home. I was discharged around 1:00pm. A prescription for an Epi Pen was made by Dr. and filled that day at pharmacy. and spoke to my Dr. at another healthcare organization at 4:30pm. Benadryl OTC was then rx'd by my primary care doctor at 4:30pm-50mg every 6 hrs moving to 25 mg every 6 hours the next day. Symptoms of swollen throat continued into the next day and have not yet abated but also have not worsened. Due to continued throat swelling I have taken 50mg of Benadryl the next day as well. Dr. my primary care Dr. scheduled an allergist appt for Feb. 3, 2021 and advised I should not get the second dose of the COVID19 vaccine until I speak with an allergist and have a treatment plan developed.
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| 48 | 2021-01-31 | lymph node swelling |
Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one n...
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Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one no pain . The second one really hurt maybe due to the person giving it . I had a fever low grade till noon 1/31/21. The scariest was pain and swelling in my lower armpit on my left arm where vaccinated. I found a study that it can happen but I freaked out . 48 after I experienced the lymphnodes swelling the pain went away but still swollen . I think this should be listed as people with a cancer history will freak out if they think their cancer is back . Lymphoma or breast . I aldd also read that vaccinated women need to alert their radiologists before a mammogram as the swollen lymphnodes could mimic Breast cancer and lymphnodes involvement, which would scare women to death . Physicians should be made aware and the public should be iNformed of the above to reduce panic and unnecessary testing .
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| 48 | 2021-02-01 | lymph node swelling |
had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen ...
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had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen lymph nodes on neck and both arm pits on 2/2, very fatigue
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| 48 | 2021-02-01 | peripheral swelling, swollen extremities |
SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT L...
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SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT LIKE THEY WERE GOING TO POP AND SOME SOB
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| 48 | 2021-02-01 | peripheral swelling |
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of ...
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I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
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| 48 | 2021-02-03 | swelling face |
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid...
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Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
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| 48 | 2021-02-04 | lymph node swelling, lymph node pain |
body aches; felt very tired; lymph node in her left armpit swelled and was painful; lymph node in he...
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body aches; felt very tired; lymph node in her left armpit swelled and was painful; lymph node in her left armpit swelled and was painful; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on 15Jan2021 at 12:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history included COVID 19. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and tetracycline and which she had an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at 20:00, the patient started having body aches , felt very tired and the lymph node in her left armpit swelled and was painful. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious.
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| 48 | 2021-02-04 | lymph node swelling |
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si...
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bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
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| 48 | 2021-02-07 | lymph node swelling, swelling |
marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left si...
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marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side; Very Painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3302), via an unspecified route of administration on 19Jan2021 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications that were received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1284), via an unspecified route of administration on 29Dec2020 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced marked swelling and swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, very painful. The patient stated she did not have redness. The clinical outcomes of the swelling, swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, and pain were not recovered. It was also reported that since the vaccination, the patient has been tested for COVID-19, the patient had PCR nasal swab on 18Jan2021, which was negative and rapid test nasal swab on 21Jan2021 which was negative.
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| 48 | 2021-02-07 | lymph node swelling |
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c...
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Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-02-07 | swollen extremities, lymph node swelling |
Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue...
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Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue continues intermittently, Sunday 2/7/2021 noticed swelling to the left axilla with enlarged lymph node continues with it today 2/8/2021
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| 48 | 2021-02-07 | swollen extremities |
Almost 24 hours after my first vaccine, I woke up from a nap and my left armpit was swollen and sore...
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Almost 24 hours after my first vaccine, I woke up from a nap and my left armpit was swollen and sore. Within a few hours, I had throbbing pain into the left side of my breast. I assumed it was from my lymph nodes reacting, but I didn't know if this is normal or expected. Also, I hadn't heard anything about swelling, tenderness in the armpit or breast discomfort. I took tylenol and ibuprofen and the breast throbbing went away before I went to sleep that night. The swelling and tenderness in my left armpit lasted for 4 days.
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| 48 | 2021-02-08 | lymph node swelling | Fever, severe body aches, chills, headache, fatigue, swollen lymph nodes |
| 48 | 2021-02-09 | lymph node swelling, peripheral swelling |
swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm ...
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swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
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| 48 | 2021-02-09 | swelling |
swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; di...
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swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; difficult to raise arm due pain; difficult to raise arm due pain, very tender to touch, felt like burning; This is a spontaneous report from a contactable Other HCP(patient). A 48-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3248), via an unspecified route of administration at Arm Left on 16Jan2021 07:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included HTN(Hypertension), HLD(Hyperlipidemia), Migraines, Depression, Herniated Discs, Arthritis. There were concomitant medications but unspecified. The patient previously took Codeine and experienced allergy. On 22Jan2021 6 days after vaccine, the patient experienced swollen, painful left axilla area, gotten progressively worse, difficult to raise arm due to pain, very tender to touch, felt like burning had continued for 3 days. The patient taken Ibuprofen, Tylenol, and Iced area as treatment for all the events. There was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the event was not recovered.
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| 48 | 2021-02-09 | swelling |
After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. P...
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After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. Patient went to urgent care. They determined that the vaccine had inadvertently been administered sub-q, not IM, leading to granuloma formation. Urgent care outlined site of reaction and instructed patient to take antiinflammatories until swelling subsides; if swelling increases beyond the drawn border then go to ER. Swelling decreased over the next several days, only small amount of redness remains on 2/8.
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| 48 | 2021-02-10 | lymph node swelling |
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was large...
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1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
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| 48 | 2021-02-10 | lymph node swelling |
headache; Headache 'in the back of head, the right side of her face behind her eyes', started gettin...
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headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility. Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and just ended up going home. She felt it was better to be at home if she was having a reaction. By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening) the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses. On Jan2021 patient experienced Hot flashes. No other vaccines were given within 4 weeks. The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of lymph nodes swollen, hot flashes and sinuses were unknown.
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| 48 | 2021-02-10 | peripheral swelling, lymph node swelling |
The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leake...
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The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leaked into the area that formed into this area; swollen cervical and supraclavicular lymph nodes on the left side/ swollen axillary lymph nodes on both sides; This is a spontaneous report from a contactable healthcare professional (Physician Assistant) reporting for self. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL0142, Dose 1, intramuscularly on 07Jan2021 07:15 (at the age of 48 years old) as a single dose in left arm for COVID-19 immunization. Medical history included ongoing undifferentiated spondyloarthropathy diagnosed more than 10 years ago. Concomitant medication included golimumab (SIMPONI), 0.5mg subcutaneous injection once a month for undifferentiated spondyloarthropathy. There were no prior vaccinations in the past 4 weeks. There were no adverse events with prior vaccinations. Two days after the vaccine on 09Jan2021 she experienced swollen cervical and supraclavicular lymph nodes on the left side. On 12Jan2021 by 09:00 she developed left knee effusion and swollen axillary lymph nodes on both sides. It was worse "now" (as of Jan252021); she states she got the Bakers cyst test, the fluid leaked into the area that formed into this area. On an unspecified date, the left calf was swollen 3/4 inch. The events did not require a visit to the Emergency Room. The events did require a visit to her rheumatologist on Friday, 22Jan2021. There reporter declined having had treatment for the events. The outcome of the left knee effusion was not recovered; left knee effusion was reported as worsened. The outcome of swollen on axillary lymph nodes on both sides, swollen cervical and supraclavicular lymph nodes on the left side was recovering. The outcome of left calf was swollen 3/4 inch was unknown. Her rheumatologist was asking if he can drain it or send fluid for any studies prior to any treatment, and for any advice or if any special markers need to be drawn in case Pfizer would like more information on this.
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| 48 | 2021-02-10 | swelling face |
allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days lat...
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allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 30Dec2020 at 09:00 (Lot number: EL0140) in the right arm and second dose on 20Jan2021 (Lot number: EL3246) in the left arm, both at the age of 48-years-old at a single dose for COVID-19 immunization. Medical history included low vitamin D, hypothyroid, Von Willebrand's, and idiopathic anaphylaxis (years ago, outgrew). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received botulinum toxin type A (BOTOX) in the forehead years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction on 31Dec2020. The events were reported as non-serious. The clinical course was reported as: The patient woke up with severe lip/facial swelling on left side of face and top lip. The patient went to doctor and they thought it was allergic reaction, but not sure if it was the vaccine. After the patient received the second dose, she had swelling two days later on right bottom side of face and lip. The patient had no lip/facial filler. The patient did not receive any treatment for the events. The clinical outcome of severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-02-11 | lymph node swelling |
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, ra...
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Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
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| 48 | 2021-02-11 | lymph node swelling | Pain and Swollen supraclavicular Lymph Nodes on left side |
| 48 | 2021-02-11 | swelling face, swelling |
facial and neck swelling 4 days after vaccine administration , seen Private physician who treated it...
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facial and neck swelling 4 days after vaccine administration , seen Private physician who treated it with Benadryl.
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| 48 | 2021-02-11 | swelling |
After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day af...
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After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day after the second vaccine I noticed a lump above my left clavicle. That evening the lump was larger and visible. The next day the lump became even larger and at one point the swelling in my neck seemed like it might impede my airway. After using a warm compress the swelling came down a little. I called the on-call doctor who recommended a follow up in the office. It wasn't until 2 days later that it wasn't visible anymore but could still be palpated. I had an appointment with my physician on Tuesday just to make sure it was a swollen lymph node. She advised it was soft and moveable and most likely a swollen lymph node but to keep an eye on it and if the swelling didn't go down in two weeks to get further testing.
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| 48 | 2021-02-12 | lymph node swelling | swollen glands/lymph nodes on the left side of the neck(BEHIND EAR) and head. painful |
| 48 | 2021-02-13 | peripheral swelling | Swelling and redness of right foot toes 1-3 at bedtime. Issue resolved on its own overnight. |
| 48 | 2021-02-15 | lymph node swelling |
1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - ...
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1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - severe x 2 days 3. Muscle/joint pain entire body and injection site - moderate x 2 days; mild continuous; 4. Fever, chills x 1.5 day 5. Fatigue - mild ongoing; 6. Swollen lymph node in neck on the left side (same side received injection).
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| 48 | 2021-02-16 | lymph node swelling |
2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, musc...
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2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, muscle pain, tiredness, nausea/upset stomach, loss of sense of taste and smell 2-6-21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-7 -21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-8-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, loss of sense of taste and smell 2-9-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, diarrhea 2-10-21 Fatigue, lymphadenopathy, vertigo 2-11-21 Fatigue, lymphadenopathy, vertigo 2-12-21 Fatigue, lymphadenopathy, vertigo 2-13-21 Fatigue, lymphadenopathy, vertigo 2-14-21 Lymphadenopathy, vertigo 2-15-21 Lymphadenopathy, vertigo 2-16-21 Lymphadenopathy, vertigo 2-17-21 Lymphadenopathy, vertigo
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| 48 | 2021-02-17 | lymph node swelling |
on the day of the vaccine my right was arm and the area where I received the vaccine was red, the ne...
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on the day of the vaccine my right was arm and the area where I received the vaccine was red, the next day the pain decreased and was almost gone by the end of the day. But on 02/17/21 at work I discovered a small bump on my right side bonecollar, without knowing what it was as I never felt it before, I decided to go to the doctor, she said it is a lymph node swelling and is about 1.5cm and could possibly be a result of the COVID-19 vaccine and that she believes it'll disappear within the next few days and might have the same results after the second vaccine.
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| 48 | 2021-02-17 | swelling face |
By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headac...
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By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headache became really severe - even when walking or chewing. My face was really hurting me; very tender by left eye. I felt so tired. I had to go home from work at 2:30. Felt very cold and I put on really warm clothes and got under three 3 blankets and I slept for three hours. I felt better by that evening, I slept normally that night. Face was very swollen under my eyes - two days after vaccine. (I have filler under my eyes - it's been a year since I had that put in.) Benadryl every six hours. It took 12 hours for pain to go away and for it to decrease. But it did help. Everything resolved.
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| 48 | 2021-02-18 | anaphylactic reaction | Anaphylaxis |
| 48 | 2021-02-20 | lymph node swelling, lymph node pain |
2 days after the vaccine my left arm pit lymph nodes grew VERY large and painful about the size of a...
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2 days after the vaccine my left arm pit lymph nodes grew VERY large and painful about the size of a tennis ball sliced in half. I also experience numerous episodes of fevers and sweating. The next day (3 days post vaccine), I developed a large red rash reaction at the injection site on my left arm. It was the circumference of a tennis ball and was hard, hot to the touch, and very painful. There was also a burning sensation. Today is the 3rd day post vaccine so I don?t have information about how long this will last. Feel free to contact me for a follow up. I just wanted to get this info out there to those that need it.
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| 48 | 2021-02-20 | lymph node swelling | Swelling of left side lymph node under my arm |
| 48 | 2021-02-21 | lymph node pain, lymph node swelling |
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende...
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arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-02-21 | lymph node swelling | swollen of the lymph node, pain on left arm that radiates to upper back |
| 48 | 2021-02-22 | lymph node swelling |
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa...
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Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
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| 48 | 2021-02-22 | lymph node swelling |
Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration...
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Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration. The next day, developed upper back pain. Symptoms have persisted for >1 month and not responding to OTC pain medication.
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| 48 | 2021-02-23 | lymph node pain |
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Sh...
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Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
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| 48 | 2021-02-23 | lymph node swelling | Swollen lymphnodes, coughing, headache, fatigue, sinus drainage |
| 48 | 2021-02-24 | swelling face |
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega...
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Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
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| 48 | 2021-02-25 | swelling face |
Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swel...
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Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swelling in the upper left of lip, swelling in the nose , itchy feeling in the left eyelid and swelling in the right eye lid. Per pt, the swelling is mild and moderately bothersome. We observed the pt for another 60 minutes and pt reported that her symptoms have subsided. However, she still experiences mild nose swelling but she stated that it was much less than before. No medication/treatment was administered. Pt went home and was instructed to contact emergency services if reactions become severe. Pt stated that she may take Benadryl at home.
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| 48 | 2021-02-25 | swelling |
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer....
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Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
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| 48 | 2021-02-27 | lymph node swelling |
Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast...
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Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast and left scapula with numbness noted 5th digit left hand approx 48 hrs after injection. Tenderness, pain increasing daily. Currently only second day post injection.
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| 48 | 2021-02-28 | lymph node pain, swollen extremities, lymph node swelling |
Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level...
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Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level was a 9 on a scale of 10. Feels like a golf ball is there but not to the touch. I barely slept the first night. I thought I was imagining the swelling but took pictures to compare left and right arm. Swelling is definitely noticeable. I didn't have Tylenol in the house so I used a wet wash cloth underneath my right arm pit to ease the pain. Helped a little bit but not much. The next night I used a refrigerated Gatorade bottle underneath my arm which worked much better. 3rd night I finally was able to get Tylenol and that seemed to help more so but I am still swollen and painful but now more tolerable.
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| 48 | 2021-03-04 | peripheral swelling |
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h pos...
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Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
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| 48 | 2021-03-05 | lymph node swelling |
9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took ...
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9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took 2 800mg tylonal 9am 3/5/2021: chills subsided All symptoms lasted until 11pm on 3/5/2021 3/6/2021: lymph node on left side swollen and sore, mild headache and mild fatigue and fogginess
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| 48 | 2021-03-06 | axillary mass |
Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful a...
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Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful armpit.
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| 48 | 2021-03-07 | swelling face |
beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge o...
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beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
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| 48 | 2021-03-07 | swelling |
I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, heada...
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I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, headache, tiredness and feeling unwell, etc. About Thursday, I noticed bumps starting to appear on me. IT was just a few and I was trying to deal with all of the other symptoms. By Friday, they started to appear more and more and are progressing as the days go on. I'm covered in bumps/rash.
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| 48 | 2021-03-09 | swelling |
Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in ...
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Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in neck near implanted surgical metal. Period started 1 week early. Resolved I?m 48 hours with rest, heat packs, Tylenol and Benadryl.
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| 48 | 2021-03-10 | swelling |
Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper l...
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Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper lip, and involving the lower lip. Accompanied by numbness for a few hours which then subsided, with lingering tenderness upon palpation.
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| 48 | 2021-03-11 | swelling, peripheral swelling, swelling face |
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im...
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Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
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| 48 | 2021-03-11 | swelling |
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. ...
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Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
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| 48 | 2021-03-13 | lymph node swelling |
Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fev...
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Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fever of 100 degrees, body aches, extreme fatigue 48 hours later: low grade fever, normal menstruation turned into extremely painful menstruation, swollen lymph nodes, sweating like breaking a fever
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| 48 | 2021-03-14 | lymph node swelling |
Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at le...
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Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at left clavicle
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| 48 | 2021-03-17 | lymph node swelling |
Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the le...
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Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the left side of my face. Within another 30 minutes, I had multiple blisters in the same spot. Within another 2 hours, the lymph nodes on the left side of my neck were swollen.
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| 48 | 2021-03-17 | swelling |
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with...
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loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
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| 48 | 2021-03-19 | lymph node pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills J...
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Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills Joint pain Nausea Feeling unwell Tender lymph nodes areas Felt feverish, but didn't take temperature
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| 48 | 2021-03-20 | swelling face |
Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I a...
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Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I am unable to give a detailed report due to this website expiring in 20 minutes. I will be more than happy to submit a complete timeline if needed.
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| 48 | 2021-03-21 | lymph node swelling |
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n...
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3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
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| 48 | 2021-03-21 | peripheral swelling |
Raised tattoo on the same arm as the vaccine occurred about four hours later. Paper cut the next d...
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Raised tattoo on the same arm as the vaccine occurred about four hours later. Paper cut the next day in the am, blood was really thin, watery. Again, paper cut about 42 hours after vaccine, thin blood.
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| 48 | 2021-03-22 | lymph node pain, lymph node swelling |
The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day...
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The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day after the injection, my muscle aches are better but now my Lymph Node under my arm is very swollen and painful
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| 48 | 2021-03-22 | swelling |
I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. ...
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I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. My side effects included: headache, fatigue, congestion, dizziness, nausea, diarrhea, chills, myalgia(lots of muscle pain), joint pain and swelling, overall weakness throughout body.
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| 48 | 2021-03-23 | lymph node swelling |
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym...
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Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
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| 48 | 2021-03-23 | lymph node swelling |
Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; ...
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Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
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| 48 | 2021-03-23 | lymph node swelling |
The morning of the 11th, I woke up quite nauseous and felt sick for a couple of days. On the 22nd I...
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The morning of the 11th, I woke up quite nauseous and felt sick for a couple of days. On the 22nd I woke up with very swollen lymph nodes above my left collarbone and in my left armpit as well as a dull headache. I also had a dry, hacking cough. Tuesday, the 23rd, the swelling was quite uncomfortable and prompted me to go to the doctor -- he did a chest x-ray and bloodwork, I'm going in for an ultrasound on my lymph nodes on Thursday, 24 March. The swelling in the lymph nodes has gone down a bit, to the extent that I can now lift my left arm, however today (Wednesday, 23 March) I woke up with a fever (102), extreme nausea, diarrhea, the headache is gone and the cough has subsided, but I cannot eat -- I'm drinking water and taking Tylenol for the fever. My pulse ox has been fluctuation between 90 - 94 all day; I am extremely exhausted and waiting for the fever to break.
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| 48 | 2021-03-23 | lymph node swelling | armpits hurting and painful, also down sides; I guess this would be swollen lymph nodes |
| 48 | 2021-03-24 | anaphylactic reaction |
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and...
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anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
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| 48 | 2021-03-24 | swelling |
severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/o...
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severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
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| 48 | 2021-03-24 | lymph node swelling, lymph node pain |
Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and v...
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Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and very sore. Soreness goes down in to elbow.
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| 48 | 2021-03-24 | lymph node swelling | Swollen lymph node over collar bone |
| 48 | 2021-03-25 | lymph node swelling |
Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and...
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Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and have a burning sensation. The lymph node in the left neck area where the rash is, feels swollen.
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| 48 | 2021-03-25 | peripheral swelling |
I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, a...
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I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, and have slight rash.
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| 48 | 2021-03-25 | swelling face |
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of...
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40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
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| 48 | 2021-03-25 | swelling face | Itching and swelling on face with uncontrollable coughing |
| 48 | 2021-03-28 | peripheral swelling |
48 hours post-injection the DIP joint of my left thumb became swollen, and stiff. Swelling increased...
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48 hours post-injection the DIP joint of my left thumb became swollen, and stiff. Swelling increased and I lost the ability to bend the thumb at all (could not hold a writing instrument). Pain was minimal, it was uncomfortable due to the stiffness & swellling. I used NSAID, had a telemedicine visit with my PCP on 1/20/21 and she advised to add ice and heat. There was slow improvement starting early February, and today 3/29/21 the swelling and stiffness are about 95% resolved. I have mostly normal range of motion with some stiffness.
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| 48 | 2021-03-30 | lymph node swelling | Swollen lymph nodes on left arm side of injection. |
| 48 | 2021-03-30 | lymph node swelling |
Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swoll...
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Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swollen , looks like an egg shape and hurts from the shoulder to the breaat. Very uncomfortable. Headache, tired, body aches - this is ok.
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| 48 | 2021-03-31 | anaphylactic reaction | Patient had an anaphylactic reaction and had to use her Epipen |
| 48 | 2021-03-31 | swelling face, peripheral swelling |
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in fa...
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started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-04-01 | lymph node swelling |
1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headach...
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1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headache within a couple of hours, chills all night (about 14 hours after vaccination); pain to area (not as bad as 1st time); golf size protrusion next to armpit, swelling under arm pit, pain to armpit area and sensitivity; tired first 2 days and then exhausted day 5 and 6; rash next to armpit of other arm.
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| 48 | 2021-04-01 | lymph node swelling |
I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vagin...
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I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vaginal bleeding that lasted about a week. I had had no spotting or breakthrough bleeding since my last peroid in September 2019. I had no other unusal side effects. I experienced the expected fatigue, sore arm and axillary lymph node swelling (12 days post vaccination).
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| 48 | 2021-04-01 | lymph node swelling |
The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pa...
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The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pain at the injection site. Took Tylenol every 4 hours all day long - fever, chills and headache did not stop. Had to spend all day in bed, could not eat, had to get someone to take care of my children - literally could not stay awake or function. Next day I woke up feverish and with a mild headache, Tylenol worked and I was able to function although I did not feel completely well. At night the fever came back and also pain in the back of the neck. Fever was not as bad as the day before. Today, Woke up with headache, tylenol worked and I am functional. No fever. The pain at site injection is reseeding; it was sore and lymph nodes of arm pit are still swollen but it does not bother me. The other symptoms were scary.
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| 48 | 2021-04-01 | lymph node swelling |
Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine...
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Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine. Patient took vaccine on Monday 3/30/21 and on Tuesday morning right when she woke up pain increased. Thursday 4/1/21 patient is now experiencing swollen glands under left arm (armpit). Patient took ibuprofen 800mg on Wed 3/31/21 around 9pm, also stated that she experienced a slight headache during the day that subsided after taking excedrin. Recommended for her to take tylenol to help with the arm pain. Patient is also waiting for an appt to see her PCP.
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| 48 | 2021-04-02 | lymph node swelling, lymph node pain |
A swollen lymph node under collar bone on 3/27/21, 2 days after having the 2nd shot on 3/25/21. Now ...
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A swollen lymph node under collar bone on 3/27/21, 2 days after having the 2nd shot on 3/25/21. Now (4/3/21) it's been a week, the enlarged lymph node is still there and painful.
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| 48 | 2021-04-02 | lymph node swelling |
By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning ...
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By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning shot location was red, swollen, raised somewhat, hot to the touch, and had spread up my arm to armpit/lymphnodes, very painful. Felt a sensation as though the allergic reaction was spreading across my chest - but no visible signs of that. Im almost 3 days out and still have swelling from injection site underarm. Separate from this, I had a constant headache that started a couple of hours after shot and is finally gone today. I had mild fever the first two days but that seems to have subsided. Was nauseous the first day. Woke up with terrible stomachache this morning followed by diarrhea. All over body aches and pains - were at their worst the first two days, today still there but less so.
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| 48 | 2021-04-03 | lymph node pain, lymph node swelling |
Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed...
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Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed from under my right arm in 2010 as treatment for breast cancer. The remaining lymph nodes were extremely sore after the second Pfizer Covid-19 vaccine. I have not had trouble with these lymph nodes since some were removed. It hurt so much I couldn?t sleep. This lasted for about a week. The doctor prescribed pain medication, but I chose not to take it. Just took Tylenol instead.
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| 48 | 2021-04-03 | lymph node swelling |
Rash near injection site, swollen lymph node on right side of jaw line, gums not healing from dental...
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Rash near injection site, swollen lymph node on right side of jaw line, gums not healing from dental work done one week ago (now bleeding, wasn?t before the shot). Symptoms are still ongoing.
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| 48 | 2021-04-06 | oral herpes |
I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer ...
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I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 11:15 (Batch/Lot number and Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included allergies, asthma, dysthymia, fibromyalgia. History of known allergies include penicillin and amoxicillin. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); lisinopril; atorvastatin (LIPITOR [ATORVASTATIN]) and atorvastatin taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 29Jan2021 at 14:15, the patient experienced I have a lip cyst/lesion and two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth. The patient don't know if this was a side effect or just a coincidence. He don't have a history of cold sores and herpes. Therapeutic measures were not received as a result of events. The outcome of the events were not recovered. Information on lot/batch has been requested.
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| 48 | 2021-04-20 | swelling face |
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin...
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became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
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| 48 | 2021-04-24 | anaphylactic reaction |
anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; mas...
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anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; massive and dangerous swelling of my tongue; an intense burning on the roof of my mouth; there were bumps forming all over the back of my tongue; blisters forming on the back of my throat; She has been very very sick; This is a spontaneous report from a contactable consumer (patient), other healthcare professional, and a physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (at the age of 48years) as single dose for Covid-19 immunization. Medical history included known allergies: mild allergy to sulfa as a child that resulted in a rash; mild allergy to Crestor that resulted in extreme gas and bloating; other medical history: type 2 diabetic that has been controlled for 8 years with no A1C higher than 7.0. The patient is not pregnant at the time of vaccination. Concomitant medications included metformin, glipizide, bupropion hydrochloride (WELLBUTRIN), lovastatin, and other unspecified medication; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 23Mar2021, she received her vaccine at 4 p.m. and experienced an anaphylactic reaction within 5 minutes, by 4:10 she was taken to the ER (emergency room) attached to the clinic due to her tongue first tingling, then burning all over her tongue, and then massive and dangerous swelling of her tongue and an intense burning on the roof of her mouth. The attending physician noted there were bumps forming all over the back of her tongue and blisters forming on the back of her throat. She was admitted for anaphylactic shock and kept at the ER for 2 hours before being transferred via ambulance to other hospital and she was admitted to the ICU (intensive case unit). She spent the next day in the ICU then 2 days in Cardiac Care, another day back in the ICU, with a 5th and final day back in the Cardiac care. All 5 days were spend trying to get her anaphylactic shock under control. She had numerous doses of EpiPen, steroids, Benadryl, and Pepcid. Her tongue never did completely stop swelling and the burning sensation has never stopped. The patient was hospitalized for 5 days. It was reported further reported that the patient was hospitalized for 6 days (also initially reported as 5 days-pending clarification) and was sent home with medications but was back in the hospital yesterday (unspecified date) because of another big blow up. She has had 2 stays in the ICU, 4 days in cardiac care and is now back in cardiac care again because of yesterday. It has been 2 weeks since she received the vaccine and it is now day 12 but it keeps coming back and she just cannot stop it. She has been very very sick, in a very severe, very rare, extreme, constant state of anaphylactic shock. She has had many Epi (Epinephrine) and is on strong steroids but it has not subsided. She mentioned that their lead pharmacist called last week but never heard any response back. Her doctor told her that they accessed a website from Pfizer which allowed them to search for adverse reactions and they mentioned to her that most of these reactions subside within 24-48 hours. She mentioned that she has no food allergies, no allergies to vaccines, and has only had minor drug reactions. This is the 1st time that this has happened to her and it is getting serious. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. The reporter (consumer) assessed the events as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 48 | 2021-04-26 | swelling, anaphylactic reaction |
Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling,...
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Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
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| 48 | 2021-05-04 | lymph node swelling |
took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals...
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took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals; Nausea; she wanted to make sure her not feeling well was normal; She had a really bad headache. Clarifying the headache started 1-2 hours after she got the first COVID-19 Vaccine shot; her (left) arm was really sore after she had the COVID-19 Vaccine, but she had expected that; She was still achy in her muscles, but not everywhere. She said her muscles ached from her shoulders up only.; she had a scratchy (sore) throat; she felt tired; she had a little bit of congestion; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a swollen lymph node in her left arm pit for the last couple days; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a pressure inside of her head/Her head doesn't feel well. She said she does not quite have a headache, but her head does not feel normal.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0170), dose 1 single dose via an unspecified route of administration in the left arm on 16Apr2021 between 3:53 PM-3:55 PM (at the age of 48 years-old) for COVID-19 vaccination. Medical history included hypermobility syndrome from an unknown date and unknown if ongoing, tends to get headaches with her hypermobility issues, and those headaches felt like pain in her head. Reported she was on the hypermobility spectrum with tension headaches, vertigo positional from an unknown date and unknown if ongoing, 3-4 weeks prior to getting the COVID-19 Vaccine, she tried to take a half of a beta blocker pill to treat the benign paroxysmal positional vertigo (BPPV). She said the BPPV had cleared, and she felt better, vestibular migraine from an unknown date and unknown if ongoing had some residual dizziness from the vestibular migraines, Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. She said she did not have a technical diagnosis for Ehlers-Danlos Syndrome (hypermobility) yet, and finally sees a geneticist next month. She said she was on the weaker end of the Ehlers-Danlos hypermobility spectrum disorder, and did not have a definitive diagnosis. She didn't drink alcohol, exercised every day and slept enough. The patient did not receive any previous immunization with the Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Cyanocobalamin and ergocalciferol were discontinued a week before she got the COVID-19 vaccine to avoid any issues.The patient experienced she had a little bit of congestion on Apr2021, she wanted to make sure her not feeling well was normal on 16Apr2021, she had a really bad headache, clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot on 16Apr2021, her (left) arm was really sore after she had the covid-19 vaccine, but she had expected that on 16Apr2021, she had a swollen lymph node in her left arm pit for the last couple days on Apr2021, after she received the covid-19 vaccine that she had some clotting, and menstrual irregularities on Apr2021, she had a pressure inside of her head/her head doesn't feel well, she said she does not quite have a headache, but her head does not feel normal on Apr2021, she was still achy in her muscles, but not everywhere. she said her muscles ached from her shoulders up onlyon 16Apr2021, she felt off/felt a little run down on Apr2021, she had a scratchy (sore) throat on Apr2021, she felt tired on Apr2021, nausea on 16Apr2021, her (left) arm was really sore on an unspecified date and swollen lymph node in her left arm pit on an unspecified date. She said it was not possible that her head pressure, and her head feeling off had anything to do with the BPPV or the vestibular migraines. She said her ear crystals had fell out since then, and what she was experiencing now must be due to the COVID-19 Vaccine. She had no fever. She only had nausea for the first 24 hours after getting the COVID-19 Vaccine. She said she had no vomiting. She said her headache had been constant since she had the COVID-19 Vaccine on 16Apr2021. The headache started 1-2 hours after she got the first COVID-19 Vaccine shot. The events did not require an emergency room or physician's office visit. The patient underwent lab tests and procedures which included blood test and urine analysis on an unknown date in Mar2021 or Apr2021: came back normal . Therapeutic measures were taken as a result of she had a really bad headache. clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot (headache). She took 2 generic Whole Foods 365 brand Acetaminophen 500mg (1000mg total): NDC Number: 42681-7076-1, Lot Number: 8HE1354B, & Expiration Date: Jun2020 in Apr2021. The events did not require an emergency room or physician's office visit. The clinical outcome of not feeling well, headache, arm was really sore, swollen lymph node, had some clotting and menstrual irregularities was recovering and not recovered for pressure inside of her head, felt off, scratchy (sore) throat , congestion, felt tired, hadn't felt 110%, recovered for nausea and unknown for achy in her muscles and ear crystals.
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| 48 | 2021-05-06 | peripheral swelling |
Broke out with bumps on upper left side of my back, left arm and hand swelling and pain in left hand...
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Broke out with bumps on upper left side of my back, left arm and hand swelling and pain in left hand that continues and hasn't went away.
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| 48 | 2021-05-07 | swelling, peripheral swelling |
Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling i...
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Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-09 | lymph node swelling, swelling face, anaphylactic reaction |
Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swel...
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Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
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| 48 | 2021-05-10 | lymph node swelling | Pt. developed painful splenomegaly and left axillary lymphadenopathy |
| 48 | 2021-05-10 | peripheral swelling, lymph node swelling |
swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ...
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swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.
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| 48 | 2021-05-11 | swelling face |
Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face w...
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Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-05-19 | peripheral swelling |
huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and ...
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huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
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| 49 | 2020-12-31 | anaphylactic reaction |
Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and fam...
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Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and famotidine. Was given prescriptions for epipen and oral steroids (60mg x 5 days).
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| 49 | 2021-01-03 | axillary mass |
Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurs...
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Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on 19Dec2020 18:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history reported. Concomitant medication included estradiol (ESTROGEN), and meloxicam. On 26Dec2020 08:00, the patient experienced golf ball size lump in armpit of injection arm. The patient did not receive treatment for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-01-03 | swollen extremities |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | peripheral swelling |
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ...
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I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
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| 49 | 2021-01-04 | lymph node swelling |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | peripheral swelling, swelling face |
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an...
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swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
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| 49 | 2021-01-04 | peripheral swelling |
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO...
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ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
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| 49 | 2021-01-06 | anaphylactic reaction | Anaphylactic reaction |
| 49 | 2021-01-06 | lymph node pain, lymph node swelling | Left axillary lymph node swollen and very painful Hard to move left arm. |
| 49 | 2021-01-06 | lymph node swelling, lymph node pain | Swollen and very painful left axillary lymph node. Hard to move the arm. |
| 49 | 2021-01-06 | lymph node swelling |
cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her l...
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cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her lt axilla
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| 49 | 2021-01-06 | swollen extremities |
Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her arm...
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Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her armpits swelled up that she was not able to put her arm down. It lasted several days.
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| 49 | 2021-01-07 | lymph node swelling |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | peripheral swelling, swelling face |
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ...
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12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
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| 49 | 2021-01-07 | swelling face |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | swelling | Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache |
| 49 | 2021-01-08 | swelling | Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins |
| 49 | 2021-01-08 | peripheral swelling | Swollen, painful left axillary lymph nodes |
| 49 | 2021-01-10 | lymph node pain | Lymph pain, low grade fever, aches |
| 49 | 2021-01-10 | lymph node pain | chills, aches, lymph pain |
| 49 | 2021-01-10 | lymph node swelling |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-10 | lymph node swelling |
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti...
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Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
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| 49 | 2021-01-10 | lymph node swelling | Swollen lymph nodes on left arm still ongoing will be seeking medical care. |
| 49 | 2021-01-10 | peripheral swelling |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-10 | peripheral swelling |
Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and...
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Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and follow up with PCP.
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| 49 | 2021-01-11 | lymph node swelling |
Lymphadenopathy in the axillary are of my left arm. I have not seen a physician regarding the lympha...
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Lymphadenopathy in the axillary are of my left arm. I have not seen a physician regarding the lymphadenopathy as I have no other signs or symptoms. I?ve read this was considered an adverse reaction and wanted to report it
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| 49 | 2021-01-11 | peripheral swelling |
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau...
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painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
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| 49 | 2021-01-11 | swelling, peripheral swelling |
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou...
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Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
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| 49 | 2021-01-12 | lymph node swelling, lymph node pain |
My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small...
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My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small pea size lump on my right collar bone area that has now increased in size to a quarter size lump that's mildly tender.
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| 49 | 2021-01-12 | lymph node swelling, peripheral swelling |
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to...
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chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
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| 49 | 2021-01-12 | lymph node swelling | soft ball size swollen lymph node under at arm pit arm of injection |
| 49 | 2021-01-12 | lymph node swelling | soft ball size lymph node under arm pit of injected arm |
| 49 | 2021-01-13 | anaphylactic reaction |
Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EM...
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Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EMS.
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| 49 | 2021-01-13 | lymph node swelling | swollen lymph nodes under arm |
| 49 | 2021-01-13 | lymph node swelling |
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on...
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-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
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| 49 | 2021-01-13 | lymph node swelling | Lymphadenopathy of left axillary area |
| 49 | 2021-01-13 | peripheral swelling, swelling face |
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p...
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Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
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| 49 | 2021-01-14 | axillary mass |
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches...
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1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
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| 49 | 2021-01-14 | axillary mass |
1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *f...
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1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *first vaccination; slight fever of 100 on days 3,4.
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| 49 | 2021-01-14 | lymph node swelling, swollen extremities |
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move...
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immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
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| 49 | 2021-01-14 | lymph node swelling |
Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph no...
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Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph nodes began afternoon 1/14/21
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| 49 | 2021-01-16 | lymph node swelling |
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe...
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Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
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| 49 | 2021-01-17 | lymph node swelling | swollen right lymph node, unable to move arm |
| 49 | 2021-01-17 | peripheral swelling, lymph node pain |
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ...
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49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
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| 49 | 2021-01-17 | swelling |
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t...
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swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
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| 49 | 2021-01-17 | white blood cell count increased |
Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as...
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Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.
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| 49 | 2021-01-18 | lymph node swelling |
Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tire...
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Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tiredness, couldn't get up, Sunday felt same way and called in to work, Monday weakness in both legs, went to work, today under arm is still sore. When i rub on deodorant underarm is very sore, left arm feels funny. Today still have migraine, i started Tylenol on Thursday, by Friday evening i was taking tylenol every 6 hours until yesterday. I used medicated over the counter pouch, put hot cloth under arm for swelling and it did go down some, but is still not back to normal. Everything i was feeling was on my left side, by Saturday whole body was aches, continued taking tylenol but now just left arm is sore. Migraine comes and goes. My doctor told me this morning she experienced everything i told her.
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| 49 | 2021-01-18 | swelling |
Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM a...
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Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM and difficulty grasping items by end of day. Day #3 Fingers improving. Day 4 Knees swollen and difficulty bending or climbing stairs, resolved by Day 5. Dose #2, Day 1- 12 hrs after injection started with joint stiffness in hands. Day #2 Finger joint swelling/pain. Day #3 finger,hand,shoulder,hip,knee and metatarsal pain/swelling/limited ROM. Day #4 (same as Day 3), DAY 5,6,7 symptoms improving: able to complete 12 hr shift at work. Day 8 finger/hand joint swelling/pain/stiffness
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| 49 | 2021-01-18 | swelling |
Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fa...
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Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fatigue, low back pain and achy all over. Much more severe then after my 1st Covid shot.
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| 49 | 2021-01-18 | swelling |
Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consum...
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Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consumer (patient, "I am Dental"). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included hydrochlorothiazide, famotidine, and montelukast. The patient experienced lower part of head was swollen in the back on 07Jan2021. The patient stated, "I got my first vaccine on 22nd (22Dec2020) and I been feeling fine until this morning when I woke up and lower part of my head is swollen in the back so I don't know it's something related or not." Patient also stated, "Because I am in healthcare and I deal with lot of saliva all day working on teeth." No treatment received for the event. The outcome of the event was not recovered.
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| 49 | 2021-01-19 | lymph node pain, swelling |
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ...
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: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
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| 49 | 2021-01-19 | peripheral swelling |
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte...
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"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
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| 49 | 2021-01-20 | lymph node swelling | Migraine Swollen axilla lymph nodes Low grade fever 100 Chills |
| 49 | 2021-01-20 | peripheral swelling |
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was g...
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A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient). A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
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| 49 | 2021-01-20 | swelling |
I lifted my left arm that same evening of the injection and under my armpit I felt swelling. The nex...
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I lifted my left arm that same evening of the injection and under my armpit I felt swelling. The next day I called my PCP and they examined my left arm, under armpit but told my lymphnodes had no swelling. Within a few days, the swelling went down.
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| 49 | 2021-01-21 | lymph node swelling |
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod...
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Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
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| 49 | 2021-01-23 | oral herpes |
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tyleno...
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fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
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| 49 | 2021-01-24 | anaphylactic reaction | anaphylaxis |
| 49 | 2021-01-24 | lymph node swelling | Swollen lymph node/gland w/ tenderness in the left arm Pitt |
| 49 | 2021-01-24 | swelling face |
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ...
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I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
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| 49 | 2021-01-25 | lymph node swelling |
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;...
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First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
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| 49 | 2021-01-25 | swelling face, anaphylactic reaction |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | swelling |
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO...
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12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
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| 49 | 2021-01-27 | lymph node swelling |
Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site...
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Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site soreness; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in left arm on 13Jan2021 00:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, anxiety and penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 (lot number EL1284) on 23Dec2020 12:00 PM in left arm for COVID-19 immunization. The patient experienced swollen axillary lymph node on same side as injection, fatigue, body aches, headache, injection site soreness on 13Jan2021 20:00. The outcome of the events was recovering. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination.
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| 49 | 2021-01-27 | peripheral swelling, swelling face |
left upper arm swelling; neck pain, mainly on left side; Headache; left sided facial swelling; This ...
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left upper arm swelling; neck pain, mainly on left side; Headache; left sided facial swelling; This is a spontaneous report from a contactable nurse (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date Apr2021), via an unspecified route of administration on 13Jan2021 at a single dose in the left arm for immunity (COVID-19 immunisation). There were no medical history and concomitant medications. The patient received the COVID vaccine and developed some symptoms on 13Jan2021. The symptoms were: left upper arm swelling, neck pain, mainly on left side, a headache, and left sided facial swelling. The patient had not recovered from the event headache. The outcome of the events left upper arm swelling, neck pain and left sided facial swelling was recovering. The events left upper arm swelling, neck pain, mainly on left side and relatedness left sided facial swelling with COVID vaccine was related.
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| 49 | 2021-01-27 | swelling face | diffuse urticarial rash. facial swelling. |
| 49 | 2021-01-27 | swelling |
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was...
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Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN. EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.
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| 49 | 2021-01-28 | swollen extremities |
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no...
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Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | peripheral swelling |
left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "somet...
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left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 49 | 2021-01-28 | swelling |
pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and s...
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pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
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| 49 | 2021-01-31 | lymph node swelling |
swollen lymph node above left clavicle- no pain Denies any other symptoms- fever, chills, body ach...
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swollen lymph node above left clavicle- no pain Denies any other symptoms- fever, chills, body aches, headaches
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| 49 | 2021-01-31 | peripheral swelling, lymph node swelling | Lymph Node swelling under right arm pit and arm. Pain the radiated from there down to fingertips. |
| 49 | 2021-01-31 | swelling face | Systemic: Other- facial swelling- lips and eyes-Medium |
| 49 | 2021-02-01 | anaphylactic reaction |
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ...
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a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
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| 49 | 2021-02-01 | swelling face, anaphylactic reaction |
Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous repo...
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Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-03 | anaphylactic reaction | Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe |
| 49 | 2021-02-03 | lymph node pain |
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf...
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Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
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| 49 | 2021-02-03 | lymph node swelling |
103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscl...
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103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscle, joint, skin aches; severe muscle, joint, skin aches; headache; lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), intramuscularly in the right arm, on 08Jan2021 at 10:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included interstitial cystitis, anxiety, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included mirabegron (MYRBETRIQ), escitalopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), and colecalciferol (VIT D3). Other concomitant medications included an unspecified multivitamin. The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, in Dec2020 at 13:30 (at the age of 49-years-old) for COVID-19 immunization. The patient experienced 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy on 08Jan2021 22:45. The events were reported as non-serious. It was reported that the severe swelling of nodes in left armpit lasted less than 3 days. The patient underwent lab tests and procedures which included body temperature: 103.0 on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcome of 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-02-03 | lymph node swelling |
Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1...
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Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1/28/21 and are ongoing.
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| 49 | 2021-02-03 | lymph node swelling |
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i...
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She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
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| 49 | 2021-02-03 | lymph node swelling |
non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensat...
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non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensation and joint pain in injection arm; 19Dec2020 she received the 1st dose. 2nd dose received 11Jan2021; This is a spontaneous report from a non-contactable consumer. A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not provided), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose on 19Dec2020 and experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. Patient's 2nd dose was received on 11Jan2021 and since 15Jan2021 she mentioned non-swollen cord like lymph nodes, burning sensation and joint pain in injection arm which transcends to the left arm. Tylenol helps sometimes. Outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
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| 49 | 2021-02-03 | swollen extremities |
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a...
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Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-03 | peripheral swelling |
Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on ...
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Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on 2/4/2021, she noticed that her right hand was swollen.
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| 49 | 2021-02-04 | lymph node swelling | swollen lymph nodes under left injection arm |
| 49 | 2021-02-05 | c-reactive protein increased |
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese...
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pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
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| 49 | 2021-02-05 | lymph node swelling |
Bilateral large (3cm) axillary LAD, persisting for > 6 weeks epitrochlear adenopathy L arm Intercost...
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Bilateral large (3cm) axillary LAD, persisting for > 6 weeks epitrochlear adenopathy L arm Intercostal adenopathy R chest
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| 49 | 2021-02-08 | lymph node swelling | headache, increased salivation, swollen mandibular gland, pain in neck radiating to ear |
| 49 | 2021-02-09 | white blood cell count increased | Headache, fatigue, tingling in hands, pain and spasms in hands, pain in left leg. |
| 49 | 2021-02-10 | lymph node swelling, lymph node pain |
pt stated she had a headache the day of the vax but the day after she woke up with pain in the armpi...
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pt stated she had a headache the day of the vax but the day after she woke up with pain in the armpit. She said the lymph nodes are tender to touch and swollen under her right arm pit. She contacted her PCP and she was told to watch it for a couple of days and if wasnt better to give him a CB.
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| 49 | 2021-02-10 | lymph node swelling |
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t...
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Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
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| 49 | 2021-02-13 | lymph node swelling, lymph node pain |
Fever of 101 started mid day on 2/9/21 with aches and pains all over, especially in bilateral armpi...
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Fever of 101 started mid day on 2/9/21 with aches and pains all over, especially in bilateral armpits and headache . I took Tylenol and Ibuprofen every 6 hours alternating every 3 hours for coverage. When I woke up Wednesday 2/10/21 morning my left armpit lymph nodes were swollen and very painful. I still had fever and all other aches and pain.. Fever broke around 5pm on Wednesday.
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| 49 | 2021-02-16 | anaphylactic reaction |
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac...
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Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-16 | peripheral swelling |
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver...
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About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
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| 49 | 2021-02-17 | swollen extremities |
Severe extremity edema, hives with pruritus. Mild shortness of breath. None of these events occurre...
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Severe extremity edema, hives with pruritus. Mild shortness of breath. None of these events occurred with first dose. Have taken Benadryl 25mg every 6 hours. Still persistant.
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| 49 | 2021-02-19 | lymph node swelling | Pain and swelling in armpit. Jaw pain on left side. Bad headache |
| 49 | 2021-02-20 | swelling face |
ON DAY 2 AFTER VACCINE WOKE UP WTIH PERIORBITAL EDEMA AND FACIAL SWELLING. DID NOT GO DOWN UNTIL DAY...
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ON DAY 2 AFTER VACCINE WOKE UP WTIH PERIORBITAL EDEMA AND FACIAL SWELLING. DID NOT GO DOWN UNTIL DAY 4 AFTER VACCINE. TOOK ALLEGRA D ALL 4 DAYS TO HELP WITH INFLAMMATION.
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| 49 | 2021-02-20 | swelling | Swollen and itchy red bump that feels warm and hard like a mosquito bite |
| 49 | 2021-02-22 | anaphylactic reaction, swelling face |
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;...
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hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-22 | lymph node swelling | Swollen lymph nodes in arm pit of left arm. |
| 49 | 2021-02-22 | lymph node swelling |
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S...
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Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
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| 49 | 2021-02-22 | swelling | small nodule, painful sweeling on shoulder blade area |
| 49 | 2021-02-23 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began t...
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Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began to feel swollen nodes under my left arm (injection arm) and developed a mild rash on my left arm. The rash worsened and spread to my torso, right arm, and both legs. I saw a teledoc on 2/16/21 who told me to take benedryl every 6 hours and pre-treat prior to getting the second shot. I took benedryl for two days, but then switched to Allegra, to reduce fatigue. Rash did not improve. I saw an urgent care provider on 2/23/21 who prescribed antihistimine, anti-itch med, and steroid pac.
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| 49 | 2021-02-24 | lymph node swelling | Lymphadenopathy, neck tenderness + stiffness, even painful in places. |
| 49 | 2021-02-24 | peripheral swelling | Pain and swelling in. arm Fever, low-grade Chills Achiness Fatigue Headache |
| 49 | 2021-02-25 | lymph node swelling |
Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was ...
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Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was but it went away. I received my second vaccination 3 days ago and the tightness is back. Accompanied by sore throat. I felt the area and the lymph node in front of my right ear and the one in my neck on ther right side are swollen. :
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| 49 | 2021-02-26 | peripheral swelling |
Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm...
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Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm where got shot and it is extremely painful.
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| 49 | 2021-02-27 | swelling face |
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no ...
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5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given; 65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
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| 49 | 2021-02-28 | peripheral swelling |
patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/nec...
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patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/neck. symptoms resolved
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| 49 | 2021-02-28 | swelling |
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120...
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Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
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| 49 | 2021-03-02 | lymph node swelling |
received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side...
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received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side of her head, left side of her neck was sore & there was a lump on her left clavicle. She went to her PCP's walk-in clinic on 2/26/2021. Diagnosed with a bright red left ear, swollen lymph nodes on the left side of her neck, clavicle & left arm pit. She was prescribed Amoxicillin for 10 days.
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| 49 | 2021-03-02 | swelling | Fever, headache, extreme swelling in shoulder/collarbone area |
| 49 | 2021-03-04 | swelling face |
Patient received first dose of Pfizer COVID 19 vaccine at 0845. Patient mentioned history of mast c...
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Patient received first dose of Pfizer COVID 19 vaccine at 0845. Patient mentioned history of mast cell activation syndrome as well as history of several anaphylactic events to the vaccinator. Patient related that she had her personal Epi-pen with her on site. Vaccinator elected to have patient wait recommended 30 minutes. At 15 minutes post vaccination, patient stated that she was experiencing the sensation of throat and facial swelling, elaborating that this is typical for her anaphylactic reactions. Patient was addressed by the PA-C on site. Upon exam, some edema of the brow bones were noted. No edema noted in the oropharynx. Dermatographia noted on the patient's tattoos, however, no generalized rash or injection site reaction noted. Heart rate and rhythm regular. Pulse 60bpm, strong. BP 118/72. Bilateral lungs clear to auscultation in all fields. No wheezing or stridor noted. Patient denied presence of cramping abdominal pains, nausea, and vomiting. Patient was provided with 10mg Claritin ODT and 25mg PO Benadryl. Patient related that she had famotidine at home that she normally takes when such events occur. At 30 minutes post po meds, Patient related she felt better and did not feel the need to be transported by EMS, though it was offered. Discussed at length with patient regarding follow up care and low initiation threshold for emergency response.
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| 49 | 2021-03-07 | lymph node swelling |
About one too two weeks post second shot, I started developing soreness under my arms. I had initial...
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About one too two weeks post second shot, I started developing soreness under my arms. I had initially thought that is was possibly pre menopausal. then a week or so later I developed lumps in my armpits. I thought this was from my deodorant. A few days ago I was told that this has been a post vaccine symptom.
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| 49 | 2021-03-07 | swelling face |
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll...
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Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
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| 49 | 2021-03-08 | lymph node swelling, lymph node pain | Extreme pain swelling lymph nodes |
| 49 | 2021-03-09 | lymph node pain |
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp...
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Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
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| 49 | 2021-03-09 | swelling |
24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vacc...
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24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vaccination complained of macular rash on the left breast above the areola. Seen in clinic on March 10, macular confluent erythema 9 x 5 cm, no induration, no pruritis, mild swelling, c/ pain in left axillary area. No nipple discharge. Afebrile. No adenopathy. BP 121/78, pulse 72, Resp. 17, T 36.1 C, Sat 91%. z
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| 49 | 2021-03-12 | swollen extremities |
1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions ...
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1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions in the past and was thus observed for 30 minutes following her injection time. 1704 ? Vitals: 99% sp02, 192/101 BP. Patient reported symptoms of itching of face, scalp, eyes, and hands. 25 mg Benadryl given by Observer. Patient placed on continuous sp02 monitor. No SOB, cough, or wheezing at this time. 1710 ? Observers called ED Nurse to let them know we would likely be sending a patient their way. 1715 - Observer was advising patient?s husband to take her to the ED when Coordinators were alerted to situation. contacting ED and allowing patient to transport themselves is not our protocol and Coordinators took control of the situation at this time. 1717 ? 1720 ? Patient moved by wheelchair to private area in the library for further evaluation. Vitals: 99% sp02, 200/119, BP, 90 HR. assessed patient. Rash but not hives are present on her chest. There is mild end-expiratory wheezing consistent with asthma history. No airway edema. No trouble speaking or swallowing. She is mildly diaphoretic but neurologically intact. 1720 ? Rapid response called for transport to ED. Sp02 98 ? 99. 1722 - Patient is starting to have increased wheezing with sp02 holding at 98%. She doesn?t have her inhaler. 1727 ? Rapid response called to say transport is 5 ? 10 minutes away. Patient still on monitor. No visible airway edema. Starting to cough and bilateral upper extremities mildly edematous. She notes her back is itching in addition to chest. 1728 ? After briefly explaining procedure to patient and obtaining verbal consent, 0.3 mg Epi Pen injection given to right lateral thigh. Vitals 192/133 BP, 91 HR, 99% 02. 1731 ? EMS arrives. Itching, wheezing, and cough have improved. Report given to EMS. Patient transported by stretcher to ED. Report had previously been given to ED and updates since then were given to EMS.
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| 49 | 2021-03-12 | peripheral swelling |
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist...
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Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
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| 49 | 2021-03-12 | peripheral swelling |
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out...
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At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
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| 49 | 2021-03-13 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 49 | 2021-03-13 | swelling, lymph node swelling |
Found right side lymph swelling starting in the right side armpit and running down to a large golf ...
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Found right side lymph swelling starting in the right side armpit and running down to a large golf ball sized lump in the right side breast, between the bottom border of the nipple and the chest wall. PMD was seen the next day, we were advised to monitor the swelling and to return if symptoms became worse. The next vaccine is scheduled for 03/25/21, an ultrasound and diagnostic mammogram is scheduled for 04-26-21. As of today 03-14-21, the swelling in the armpit has resolved, the lump in the breast is now ~75% smaller than when originally discovered. No fever or streaking noted.
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| 49 | 2021-03-15 | swelling face | Fever, left side face swelling and drooping |
| 49 | 2021-03-16 | lymph node pain |
On 1/18/2021 I started having very swollen lymph nodes they were very painful it lasted about 2 mont...
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On 1/18/2021 I started having very swollen lymph nodes they were very painful it lasted about 2 months to go completely away.
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| 49 | 2021-03-17 | lymph node swelling | enlarged lymph node under left arm |
| 49 | 2021-03-18 | lymph node swelling, swelling face |
Day after shot felt very tired with headache and sore all over especially joints. Starting on the m...
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Day after shot felt very tired with headache and sore all over especially joints. Starting on the morning of the second day after swelling in glands around my underarm. The one between my underarm and breast is the size of about 2.5 golf balls placed side by side. Some swelling in face on same side and gland under cheek, near ear swollen. All very sore and uncomfortable.
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| 49 | 2021-03-20 | lymph node swelling |
Fevers throughout the day of the vaccine and the following day. Body aches the first two days. Left...
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Fevers throughout the day of the vaccine and the following day. Body aches the first two days. Left armpit glands are swollen.
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| 49 | 2021-03-21 | swelling |
skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy ...
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skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy legs,back, abdomen, arms, armpit,elbow, behind knee - all affected.
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| 49 | 2021-03-22 | lymph node swelling |
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fa...
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Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
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| 49 | 2021-03-22 | swelling face |
bumps in mouth on first day, face turned read on second day and bumps went away, third day lips beca...
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bumps in mouth on first day, face turned read on second day and bumps went away, third day lips became raw and almost wind burned and chapped then fourth and fifth day lips swelled up very large as well as chin and lower face and cheeks. Benadryl, claritin given together as well as epi pen for emergency use.
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| 49 | 2021-03-25 | anaphylactic reaction |
Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reactio...
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Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.
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| 49 | 2021-03-25 | swelling face |
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me...
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
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| 49 | 2021-03-27 | lymph node swelling |
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ...
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Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
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| 49 | 2021-03-29 | lymph node swelling |
2 supraclavicular nodes on L (node 1- size of dime; node 2- size of penny); nodular swelling noted o...
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2 supraclavicular nodes on L (node 1- size of dime; node 2- size of penny); nodular swelling noted on March 28, 2021; symptoms still present. L arm swelling/ tenderness/ pain at injection site noted on March 27, 2021; symptoms are improving.
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| 49 | 2021-03-29 | lymph node swelling |
At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minut...
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At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minutes. At 90 minutes, drop in blood pressure, dizziness, weakness, severe stomach cramps, nausea, vomiting, diarrhea, tightness in chest and head. Took Benadryl, Albuterol and Pepcid. One hour later, 103 fever, severe pain in all joints. Stayed on Benadryl for 24 hours. Once Benadryl was stopped, developed hives all over chest, various spots on arms and stomach, continued dizziness, swollen lymph node in arm pit. Eyes were swollen and itchy. and red. Resumed Benadryl x5 days, every time Benadryl stopped, hives resumed. . Periodic hives still surface as of this date but mostly improved. My MD suggested I report event.
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| 49 | 2021-03-30 | anaphylactic reaction |
Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (pat...
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Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
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| 49 | 2021-03-30 | axillary mass |
I got the vaccine on Monday, March 29th around 1:30 pm, I was perfect, don't even arm pain. In the e...
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I got the vaccine on Monday, March 29th around 1:30 pm, I was perfect, don't even arm pain. In the early morning of the 31st, around 2:00 am, I felt pain under my armpit that was reflecting towards the left breast. I also felt pressure in my left arm but more toward my forearm and a discomfort in the left side of my core and in my back (left side). I sat up, raise my arm and felt a lump of about 3 inches in diameter, under my armpit. I took Naproxen of 500Mg.
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| 49 | 2021-03-30 | lymph node swelling |
fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose...
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fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla; This is a spontaneous report from a contactable Other Health Professional. A 49-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 14:30 (Batch/Lot Number: EL8982) as single dose for covid-19 immunization. Medical history included historical vaccine, dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 at 14:45 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunization. Concomitant medication included lansoprazole (PREVACID) taken for an unspecified indication, from unspecified date. Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla on 02Jan2021 08:00 AM. The patient had fever and headache The patient was treated ibuprofen for fever and headache. The patient underwent lab tests and procedures which included, Nasal Swab (labcorp pixel): negative on 29Jan2021. Facility type vaccine is Clinic Name. The outcome Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla was not recovered and outcome for fever and headache was unknown.
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| 49 | 2021-03-30 | swelling face |
Developed rash on contralateral arms @ 20 minutes then spread to rest of body. Then developed SOB/fa...
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Developed rash on contralateral arms @ 20 minutes then spread to rest of body. Then developed SOB/facial swelling. Received Epi pen x1 with some response, and brought to ED. VS remained stable 150-160/100-110. Exam notable for diaphoresis, RRR, CTAB no wheezes.
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| 49 | 2021-03-31 | anaphylactic reaction |
reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/d...
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reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/dizzy, VSS, developed mild SOB/clammy/groggy, sent to Emergency Room for evaluation and treatment where it was documented that she had an anaphylaxis reaction to the vaccine administered at 0800 on the same day at a community vaccination event
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| 49 | 2021-03-31 | lymph node swelling |
Developed body aches, chills for total of four days after vaccine and symptoms resolved. Then a week...
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Developed body aches, chills for total of four days after vaccine and symptoms resolved. Then a week after recieving the vaccine she developed arm pain around site of injection, a bright red rash, and swollen, tender lymph nodes at right axillae.
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| 49 | 2021-04-01 | lymph node swelling |
A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-s...
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A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-sized swollen supraclavicular lymph nodes and have extreme collar bone and a/c joint/shoulder pain. I read case studies about other vaccine recipients who had a lymphadenopathy in similar areas, so I will wait to see if it clears up before seeing a doctor.
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| 49 | 2021-04-01 | swelling face |
Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to pati...
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Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
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| 49 | 2021-04-02 | lymph node swelling, lymph node pain |
Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is;...
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Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on Right arm on 08Feb2021 12:00 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included back disorder and Chronic back problems. Concomitant medications within 2 weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient experienced right arm pit is swollen, lymph nodes are sore and puffed up and big noticeable bubble where armpit is on 09Feb2021 05:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of events were not recovered.
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| 49 | 2021-04-02 | swelling face | 8:06 am Patient having feeling of swollen tongue and face puffing |
| 49 | 2021-04-03 | lymph node pain |
lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report...
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lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Feb2021, 10:45 AM at arm left as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.no other vaccine was administered in 4 weeks. The patient was on birth control. On 13 Feb 2021, at 05:00Am the patient experienced Soreness at injection site Chills and No fever. on 14 Feb 2021, she had lymph nodes left arm pit and it was very sore. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-04-03 | lymph node swelling | Fever and chills, then very painful right shoulder joint and very swollen lymph in right axilla. |
| 49 | 2021-04-13 | anaphylactic reaction, swelling |
Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. ...
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Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
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| 49 | 2021-04-16 | swelling face |
Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primar...
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Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primary care doctor for further testing, blood labs, endocrinologist visit and additional labs. Vision care for vision loss.
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| 49 | 2021-04-17 | anaphylactic reaction |
anaphylaxis; sneezing; throat swelling; Continued having breathing difficulty; coughing; This is a s...
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anaphylaxis; sneezing; throat swelling; Continued having breathing difficulty; coughing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: OCDPH) via an unspecified route of administration, administered in the left arm on 10Mar2021 16:15 (at the age of 49 years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included Crohn's Disease and chronic Migraines. Patient has allergies to medications, food, or other products such as Milk Protein and Compazine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included midodrine taken for an unspecified indication, start and stop date were not reported; and rizatriptan benzoate (MAXALT) taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 16:30 (as reported), patient was sneezing within 5-10 minutes of receiving dose, had anaphylaxis within 15-20 minutes of receiving dose. She continued having breathing difficulty, sneezing, coughing and throat swelling for 5 days which was treated with Benadryl. Second dose of Epipen was required 20 hrs. later and continued use of Benadryl, Allegra and inhaler for 4-6 days. Continued issues with over stimulation of allergic reaction to other known allergies continues. The outcome of events was reported as recovered with sequelae. The events required emergency room and physician's office visit. Therapeutic measures taken as a result of the events included EpiPen, Steroid, Benadryl and inhaler (unspecified). The events were assessed as serious, life threatening illness (immediate risk of death from the event). Follow-up attempts are completed. The information on the batch/lot number has already been obtained.
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| 49 | 2021-04-22 | peripheral swelling, lymph node pain, swelling face, lymph node swelling |
All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes...
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All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
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| 49 | 2021-04-24 | anaphylactic reaction |
I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from...
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I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from the shot. I got in my car and about 5 minutes out driving in the middle of traffic, I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel. There is no mistaking the feeling. I could not feel my pulse at all. Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful. I then took benadryl as advised and the EMS were called. I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening. I was told to take benadryl for the next 24 hours and I did.
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| 49 | 2021-04-25 | lymph node swelling | Swollen lymph node on neck. |
| 49 | 2021-04-26 | lymph node swelling |
About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left...
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About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left,Rash worsened on my left arm expanded to my torso, right arm and legs; This is a spontaneous report from a contactable Other health care professional. A 49-year-old female non-pregnant patient (Other HCP) received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN5318) via an unspecified route of administration in arm left on 06Feb2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Concomitant medications included Levothyroxine, vitamin D (COLECALCIFEROL). No covid prior vaccination and no covid tested post vaccination. On 10Feb2021, the patient reported that about 3 to 4 days after injection, patient noticed swollen lymph nodes under her left arm (injection arm) and rash on left arm. Rash worsened on patient left arm, expanded to her torso, right arm, and legs. The patient received treatment for the events via unspecified treatment medications as anti-itch meds, antihistamine and steroid pack. The outcome for the events was not recovered.
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| 49 | 2021-05-03 | peripheral swelling |
I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have h...
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I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 49 | 2021-05-07 | swelling |
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo...
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2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
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| 49 | 2021-05-10 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
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| 49 | 2021-05-11 | lymph node swelling |
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h...
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was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-05-12 | lymph node swelling |
swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (res...
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swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (resolved), tingling in lips (resolved), numbness left side of face (continuing)
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| 49 | 2021-05-12 | oral herpes |
I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at ...
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I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later. I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
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| 50 | 2021-01-03 | lymph node swelling, lymph node pain | Swollen painful lymph node left clavicle |
| 50 | 2021-01-04 | peripheral swelling, lymph node swelling |
temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lym...
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temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lymph nodes
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| 50 | 2021-01-04 | swelling face |
day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days ...
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day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
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| 50 | 2021-01-04 | swelling |
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he...
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underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
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| 50 | 2021-01-05 | anaphylactic reaction |
anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-o...
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anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-05 | swelling face |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-05 | swelling |
Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light head...
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Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.
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| 50 | 2021-01-05 | white blood cell count increased |
Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trou...
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Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trouble breathing but substernal chest pain 8/10. Vital signs- Temp-97.9 Pulse-95 BP- 162/100 Resp- 22 oxygen saturation- 95 @ room air. 1600- transported to ER for evaluation and treatment.
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| 50 | 2021-01-06 | lymph node pain | tinnitus, face tingling, lymph pain, general muscle pain |
| 50 | 2021-01-06 | swelling face |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-07 | anaphylactic reaction | Anaphylaxis with a hives, itching, and airway involvement |
| 50 | 2021-01-07 | lymph node swelling | Swollen Axillary Lymph Nodes up to the breast area. |
| 50 | 2021-01-08 | lymph node swelling, lymph node pain |
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot ...
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Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)
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| 50 | 2021-01-08 | peripheral swelling |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-09 | lymph node swelling | Headache, Myalgia, Fever, Diaphoresis, swollen glands L>R Narrative: |
| 50 | 2021-01-09 | lymph node swelling |
After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the ...
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After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.
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| 50 | 2021-01-09 | swelling | Low grade fever, large hard painful lump in right arm, achy joints |
| 50 | 2021-01-10 | lymph node swelling, swelling |
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at sit...
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Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening 4 days after vaccine given (2nd dose)
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| 50 | 2021-01-10 | lymph node swelling | lymphadenoma |
| 50 | 2021-01-10 | lymph node swelling |
Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER...
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Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER visit.
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| 50 | 2021-01-11 | lymph node pain |
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod...
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day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
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| 50 | 2021-01-11 | lymph node swelling | Severe head pain, severe muscle pain, vomiting Fever 101.8, swollen right axillary lymph node |
| 50 | 2021-01-11 | lymph node swelling |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-11 | lymph node swelling |
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of sympto...
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Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
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| 50 | 2021-01-12 | lymph node swelling |
Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and s...
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Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and sore if I let my arm hang down at my side.
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| 50 | 2021-01-12 | swelling face |
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi...
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Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
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| 50 | 2021-01-13 | c-reactive protein increased |
HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who pr...
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HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who presented to hospital with cough and diarrhea. The patient had felt the symptoms on 12/31/2020 and eventually went to have a COVID test on 1/1/2021. She was subsequently positive but due to dehydration and diarrhea she came to the emergency department where she was admitted for remdesivir and dexamethasone. She was able to be weaned off any supplemental oxygen. Her diarrhea resolved. She is feeling well and will be discharged home in good condition.
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| 50 | 2021-01-13 | lymph node swelling |
Two days after first vaccine, patient states that she experienced lymphadenopathy of left armpit. Re...
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Two days after first vaccine, patient states that she experienced lymphadenopathy of left armpit. Resolved without treatment after a week.
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| 50 | 2021-01-13 | lymph node swelling | Swollen lymph node warmth area fever pain |
| 50 | 2021-01-13 | peripheral swelling |
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar...
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"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
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| 50 | 2021-01-14 | anaphylactic reaction |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | swollen extremities |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | swelling |
old scar that I forgot that I have there, it just swelled up really bad; The injection site looked l...
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old scar that I forgot that I have there, it just swelled up really bad; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; Injection site began to itch; Injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142 (also reported as EL0140, pending clarification), expiry date: 03Mar2021 (also reported as 31Mar2021, pending clarification), intramuscular on the right arm on 08Jan2021 06:30 at a single dose for covid-19 immunisation. Medical history included heartburn, hot flashes, Grave's disease (father also has Grave's disease), had a thyroidectomy in Dec2015, menopause, weight loss, and appetite control, allergies, compromised immune status (brother and father side with autoimmune), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, and diabetes type 2 diagnosed in 2019 (both parents and brother also with diabetes). Concomitant medications included levothyroxine sodium (SYNTHROID) in Dec2015 for Grave's disease and had a thyroidectomy, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) on 02Jan2021 for heartburn, phentermine for weight loss and appetite control, estradiol on 02Jan2021 for hot flashes and menopause, medroxyprogesterone acetate (PROVERA) on 02Jan2021 for hot flashes and menopause, prednisone for unexplained whelps (pending clarification), and cimicifuga racemosa (also reported as black cohosh) for hot flashes. The patient previously took metformin and experienced GI upset (she quit taking metformin/it was causing GI upset because they increased dose/current dose is 1,000mg twice daily increased from 500 mg twice daily) and generic levothyroxine sodium and experienced feels like crap. The patient had no previous history of immunization with the Pfizer vaccine. No additional vaccines administered on same date of the bnt162b2. No prior vaccinations within four weeks. The patient wanted to know if she can receive the second dose of the Covid vaccine after experiencing adverse events. On 08Jan2021, the patient experienced some injection site soreness, in which she took TYLENOL for. Around 14:30, she noticed that the injection site began to itch. Around 16:00, the injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle. The patient also reported, "scar that I have on my arm, it is not a reaction, it is an old scar that I forgot that I have there, it just swelled up really bad." Event injection site looked like a smallpox vaccine was assessed as serious-other medically important condition. No emergency room or physician's office required. Therapeutic measure was taken as a result of injection site soreness. Outcome of the event injection site looked like a smallpox vaccine was not recovered. Outcome of the events injection site soreness, injection site began to itch, vaccination site erythema, vaccination site scab, vaccination site discoloration, and old scar that I forgot that I have there, it just swelled up really bad was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event vaccination site discomfort cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-15 | peripheral swelling |
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ...
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Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
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| 50 | 2021-01-17 | swelling face | SEVERE SWELLING OF LEFT EYE LID AND MILD SWELLING LEFT SIDE OF HER FACE. REDNESS. |
| 50 | 2021-01-18 | c-reactive protein increased |
Fever with chills and headache for atleast 4 days after 7 days of 2nd shot of Pfizer vaccine. No ac...
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Fever with chills and headache for atleast 4 days after 7 days of 2nd shot of Pfizer vaccine. No aches and pains or malaise or any respiratory symptoms. No immediate sideeefects at all. Negative for Covid and all labs except inflammatory markers like C-reactive protein and ESR elevated. Tested negative for the flu also. ESR 90, C-reactive protein 6.4.
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| 50 | 2021-01-18 | peripheral swelling |
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj...
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Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
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| 50 | 2021-01-18 | peripheral swelling |
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe...
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Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
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| 50 | 2021-01-18 | swelling face |
Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving ...
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Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving the vaccine. Patient reported face swelling, throat tightness, and slight difficulty of breathing later that same evening. Patient self treated with benadryl and her symptoms resolved.
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| 50 | 2021-01-19 | lymph node pain, lymph node swelling |
Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of inj...
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Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of injection. All accompanied by the usual fever, body, and joint aches which subsided at 48 hours after injection. Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling still present.
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| 50 | 2021-01-19 | peripheral swelling |
2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue...
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2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue and swelling in her hands and ankles. Symptoms were significant until 1/11/21 but have been improving.
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| 50 | 2021-01-19 | swelling face |
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell...
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Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
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| 50 | 2021-01-20 | lymph node swelling |
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ...
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inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-20 | swollen extremities, lymph node pain | Large amount of edema under left armpit (size A cup) with very sore glands in same position. |
| 50 | 2021-01-21 | anaphylactic reaction |
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu...
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Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
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| 50 | 2021-01-21 | peripheral swelling | 3x2, red, hard, swollen, painful, itchy patch in arm |
| 50 | 2021-01-22 | swelling face, lymph node swelling, swelling | Had swelling and lymph nodes in my neck, had face and neck swelling. |
| 50 | 2021-01-24 | lymph node swelling |
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh...
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Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
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| 50 | 2021-01-24 | swelling face | Itchy face, tongue swelling, face swelling |
| 50 | 2021-01-27 | white blood cell count increased |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-28 | lymph node swelling, axillary mass |
Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump...
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Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump swelling under arm that I got the shot in. Low grade fever resolved with motrin. Heart remained elevated for almost 48 hours. My resting heart rate is in the upper 50's. It was in the 90's during this time. Lump (swelling) under arm is getting smaller but still noticeably there 3 days later.
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| 50 | 2021-01-28 | lymph node swelling, peripheral swelling |
severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm ...
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severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm pit ( injection arm); developed very mild headache; severe chills; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 13Jan2021 07:45 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included loratadine, progesterone, docosahexaenoic acid, eicosapentaenoic acid (OMEGA 3 FISH OIL), colecalciferol (D3), cyanocobalamin (B12). The patient previous received the first dose of bnt162b2 (lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 06:00 AM for COVID-19 immunization. The patient experienced developed very mild headache on 13Jan2021 11:00, severe chills on 13Jan2021, muscle aches on 13Jan2021, severe swollen lymph nodes to left arm pit on 14Jan2021. The treatment paracetamol (TYLENOL) and ibuprofen (ADVIL) was used. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Approximate 4 hours post second vaccine dose, developed very mild headache, followed by, approximate 15 hours post second dose, severe chills, muscle aches, lasting about 8 hours, followed by, approximate 24 hours post second dose, severe swollen lymph nodes to left arm pit (injection arm), lasting approximate 24 hours. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Not Known allergies.
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| 50 | 2021-01-30 | lymph node swelling |
Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shou...
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Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shoulder and a bit sore; I even proceeded to work after the shot and never thought that the effect of the 2nd dose is severe; Jan 6-8, 2021, (Wed-Fri) @ 11:00am - took covid vaccine 2nd dose, proceeded to work. @4:00pm - sent me home; felt the adversed reactions: left side weakness and numbness from shoulder to foot, fatigue, chills, headache; took naproxen as needed, helped somehow to ease the pain; chills were on and off; Jan. 9, 2021 (Sat ) - continuous monitoring, took Naproxen; No headache; Still present is left side weakness and numbness; new symptoms - sore/pain in left shoulder, swollen in and around left shoulder, underarm, chest and back; lymph node is also swollen and tender; chills in the evening; Jan 10 - continuous monitoring, symptoms still present with sore and pain, , taking naproxen as needed somehow helped when the med kicked in but pain?s back after the effect; Jan 11, took pain med, managed to go to work from 12:00nn continuous until 4:00pm; the pain got worsen, due to pushing and pulling of beds and wheelchairs with patients; I emailed the Covid19 Employee Health, CC'd to my Manager, informed them about my current condition and made PCP appt on Jan 15. Covid19 Employee Health replied in email with instructions to keep the appointment for Jan 15 and take covid test.. then my Manager sent me home. Jan 12, as per advice, took my Covid19 swab test, turned out Negative ; Jan 15, more pain and couldnt hold anything or even raise my left arm; in and around my left shoulder, chest, underarm and back are still swollen and tender. I went to my scheduled PCP appointment, they prescribed me Prednisone and Hydrocodone(PRN) for pain for 5 days and also recommended me to see a Specialist and a special test such as CT or MRI. If the pain doesnt go away, a follow up appointment was also advice. They are also expecting to send them paperworks related to this work injury/illness; Jan 18, continuous monitoring, sore and swelling still exist; emailed me saying that they been notified for my injury/illness report; In the link of the email, it said that they will send me the documents packet to be filled out and my PCP is also expecting for the papers but havent recieved yet; Jan 21, Yesterday was my 5th day of taking prednisone.. As of today, my left shoulder and around chest, underarm and back are still sore and swollen. The prednisone helped during the day but pain still present at night and when in bed. Some nights I hardly sleep even putting some pillows around.. During the day, I am trying to slowly raise my left arm holding it with my right hand and do some stretchings too. Despite all of these efforts, the progress is slow and pain is still exist. I sent an update to my PCP and to my Manager; My PCP sent me a reply saying that she would order for an Imaging but still waiting for the documents packet to be filled out and signed but havent received it yet. Jan 22, took pain med this morning, pain is just #5, but still hardly raise much of my left arm, still sore and swollen around my shoulder; chills and headace no longer present; i just experienced them on and off in my first 4 days after the 2nd dose; slowly raising my left arm with the help of my right hand; doing stretching too Jan 25, 2021. Today, I'm still out from work. my swollen left shoulder is subsiding but 'Im worried about the sore and swelling around it like in my chest, underarm and back. I can now raise my left arm but there is still pain, still weak and no grip. Yesterday, I got my claim number thru Portal and gladly received the hardcopy of the said docs packet on the mail today. I have also a follow-up appointment with my PCP tomorrow, 10:45am and hopefully will get an imaging order.
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| 50 | 2021-02-01 | lymph node pain, lymph node swelling |
left armpit and left breast lymph node swelling; left armpit and left breast lymph node swelling and...
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left armpit and left breast lymph node swelling; left armpit and left breast lymph node swelling and still hurting; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 15Jan2021 at 09:15 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was a diabetic; penicillin, crustacean, rye, wheat and barley allergy; and COVID-19 diagnosed prior to the vaccination. Concomitant medications included metformin, atorvastatin, dapagliflozin propanediol monohydrate (FARXIGA) and an unspecified hormone replacement. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 15Jan2021 at 13:00, the patient experienced left armpit and left breast lymph node swelling, which was still hurting and swelling at the time of this report. The events resulted in a doctor or other healthcare professional visit. The patient was treated with ibuprofen (ADVIL) every 6-8 hours for pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of left armpit and left breast lymph node swelling and still hurting was not resolved at the time of this report. information on the lot/batch number has been requested.
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| 50 | 2021-02-01 | lymph node swelling, swelling |
Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. Th...
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Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. The area below the clavicle- chest wall above left breast was swollen and tender. This has lasted going on a week and is starting to dissipate, but still there. Day after #2 vaccine I also had fever 100.5 for 12 hours, chills and headache. Brain fog for 2-3 days post vaccine
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| 50 | 2021-02-01 | lymph node swelling |
On 1/17/21 at approximately 8:00 p.m., Patient noticed her lymph nodes were swollen on the left side...
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On 1/17/21 at approximately 8:00 p.m., Patient noticed her lymph nodes were swollen on the left side and she was unable to move her neck. She was better by 1/24/21
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| 50 | 2021-02-01 | lymph node swelling |
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing...
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Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
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| 50 | 2021-02-01 | lymph node swelling |
Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in l...
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Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in lungs when breathing.
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| 50 | 2021-02-01 | lymph node swelling |
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d...
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Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient reported next day of having swollen lymph nodes, soreness, chills, slight headache--
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| 50 | 2021-02-01 | swelling |
Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed head...
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Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed headache & neck pain. Took benadryl then saw MD. Started prednisone & hydrocortisone cream on 2/1/21.
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| 50 | 2021-02-02 | swollen extremities |
Hinchazón en el borde de la axila izquierda, dolor de cabeza, dolor en los huesos, fiebre, escalofr...
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Hinchazón en el borde de la axila izquierda, dolor de cabeza, dolor en los huesos, fiebre, escalofrÃos, sudoracion excesiva, dolor en parte baja de ambos pulmones.
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| 50 | 2021-02-03 | lymph node swelling | SWOLLEN AXILLARY LYMPH NODE IN RIGHT ARM WHERE INJECTION WAS GIVEN |
| 50 | 2021-02-03 | peripheral swelling |
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; hea...
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Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional. A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
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| 50 | 2021-02-03 | peripheral swelling |
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where...
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her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore and where she got the shot was a little red, warm, and swollen. There were no relevant tests done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen was not recovered.
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| 50 | 2021-02-03 | swelling, swelling face, oral herpes |
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extr...
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Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin. Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
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| 50 | 2021-02-03 | white blood cell count increased |
Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room....
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Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room. Work up revealed acute appendicitis and I was scheduled for emergency laparoscopic appendectomy the following day.
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| 50 | 2021-02-04 | peripheral swelling |
I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm wa...
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I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm was pink.
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| 50 | 2021-02-04 | white blood cell count increased |
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient...
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ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
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| 50 | 2021-02-05 | peripheral swelling | Bumps on finger, some swelling with pinkness around. |
| 50 | 2021-02-08 | peripheral swelling |
Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter p...
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Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter pain relievers, tried cold and warm compresses. Redness, warmth, and lump resolved after 3 weeks. Still will left arm pain. Painful to lift and abduct arm.
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| 50 | 2021-02-09 | lymph node swelling | Chills, slight fever, swollen lymph node (under left arm), body aches |
| 50 | 2021-02-09 | peripheral swelling, lymph node swelling | Swollen arm and swelling in armpit area size tennis ball. Tylenol. Day 3 and 4 post vaccine |
| 50 | 2021-02-10 | lymph node swelling |
Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable o...
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Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. The patient medical history were not reported. There were no concomitant medications. The patient previously took keflex [cefalexin monohydrate] and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO142), via an unspecified route of administration on 31Dec2020 13:00 at a single dose on left arm for COVID-19 immunization. The patient experienced enlarged lymph node and soreness above left clavicle on 21Jan2021 20:00. No treatment received for the events. The outcome of the events was not recovered. The events were considered as non-serious. The patient was not pregnant. No other vaccines within 4 weeks prior to the COVID vaccine. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. Information on the lot/batch number has been requested.
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| 50 | 2021-02-10 | lymph node swelling | Enlarged lymph nodes in axilla and by clavicle; headache, fatigue |
| 50 | 2021-02-10 | lymph node swelling |
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare...
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Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
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| 50 | 2021-02-10 | lymph node swelling | Left axillary lymphadenopathy |
| 50 | 2021-02-10 | peripheral swelling, lymph node pain, lymph node swelling |
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 ho...
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Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
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| 50 | 2021-02-10 | peripheral swelling |
Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints ...
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Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
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| 50 | 2021-02-10 | peripheral swelling |
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ...
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Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
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| 50 | 2021-02-10 | swelling face, lymph node swelling |
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ...
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I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
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| 50 | 2021-02-11 | swelling |
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d...
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reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
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| 50 | 2021-02-12 | lymph node swelling | Vomiting, rigors, headache, left axillary lymphadenopathy and breast tenderness |
| 50 | 2021-02-13 | peripheral swelling |
Throat was a little swollen by the first nite. Second day had bump and red swollen rash on left arm ...
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Throat was a little swollen by the first nite. Second day had bump and red swollen rash on left arm size if silver dollar and by third day it had become a little larger and was itchy.
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| 50 | 2021-02-14 | swollen extremities |
swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never ...
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swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never had any history of egg allergy in the past)
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| 50 | 2021-02-14 | white blood cell count increased |
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc...
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She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
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| 50 | 2021-02-15 | lymph node swelling |
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red,...
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Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
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| 50 | 2021-02-15 | peripheral swelling |
I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. ...
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I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. This foot was the one that hurt a little before vaccine. It was in the center of my foot where the arch is but inside the foot - an achy pain. It would shoot through my foot with pain if I stepped a certain a way. I was limping a bit. I tried to stay off my feet as much as I could. It continued through Christmas holidays. December 28 -(my PCP) - she thought it was tendonitis - could see a red circle and swelling where most of the pain was. Dec 28 - x-ray of foot was done. There was no fractures Meloxicam - anti-inflammatory 15 mg daily starting 12/28/2020. Pain continued - trouble walking and started having hip pain and left leg pain maybe from compensating. I saw Dr. on January 7th. He said it was posterior tibialis tendonitis. He gave me a foot brace to wear - around ankle and foot. It helped but I was still having pain. I was still taking Meloxicam every day. A chiropractor and a physical therapist -they gave me foot exercises and leg exercises and that has been helpful - I see them once a week still. Dr check-up on February 9 and he ordered an MRI and I had that done on February 11th. Report says Tendinopathy and not tendonitis. I got the second dose on January 8th.
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| 50 | 2021-02-16 | lymph node pain, lymph node swelling |
After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a s...
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After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a sore arm (significantly more than after the 1st), had a massive headache for about 24 hours, but woke up this morning (2nd day after the shot) with swollen nymph nodes under my left arm along with pain and tenderness. It hurts to lift my arm or have anything putting any form of pressure on it.
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| 50 | 2021-02-16 | lymph node swelling | Soreness in arm, extreme body aches, headache, low-grade fever, fatigue, Swelling in left armpit |
| 50 | 2021-02-16 | swelling face | Flush face chest, swollen checks , lips, tongue, had issues talking |
| 50 | 2021-02-17 | c-reactive protein increased |
Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Va...
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Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Various sxs from high fever 103.1, body pains to complete spine, hips, various toes and left lower back over kidney felt sore.. Now shoulders hurt. Asked job for FMLA forms.
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| 50 | 2021-02-18 | anaphylactic reaction |
Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, receive...
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Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, received PCP clearance to receive COVID-19 vaccine. Patient given Pfizer vaccine # 1 (lot # EN6201). Approximately 12 minutes into 30 minute wait she began to report that she had a "sore/scratchy" throat and took Benadryl 50 mg PO (patients own supply). Patient took medication on her own and was given permission to take by NP. Patient was assessed by NP with breath sounds CTAB, no wheezing or stridor. No visible swelling of the lips, tongue or face. No rash. VS: B/P 124/73, HR 110, SaO2 100% on RA. During assessment she began to clear her throat and therefore was taken to Facility for further evaluation and monitoring. At Facility, pt was monitored for about 30 minutes. Pt admitted to be anxious about the vaccine. Pt received no medications from Facility. Pt instructed to use diphenhydramine Q6-8 hrs PRN. Pt was discharged to home.
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| 50 | 2021-02-18 | lymph node swelling |
2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Adv...
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2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Advil and got a little relief - fever broke early morning of 2/05/21, remained nauseous for two days and exhausted for two weeks with brain fog Sore throat off and on, swollen glands off and on, occasional ear pain - this could be related to drainage, cause unknown 2/15/21 (about) sores began showing up - first two on the back of my left hand, then one on my left upper arm, today one on my right upper arm
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| 50 | 2021-02-19 | lymph node swelling |
Fever, Headache, Pain at injection site, Fatigue, Muscle pain, Chills, Joint pain, Injection site sw...
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Fever, Headache, Pain at injection site, Fatigue, Muscle pain, Chills, Joint pain, Injection site swelling and redness, Malaise, Lymphadenopathy
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| 50 | 2021-02-22 | swollen extremities |
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl...
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Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
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| 50 | 2021-02-22 | peripheral swelling, swelling face |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-23 | lymph node swelling |
Dull headache in back of head and back of neck rated 7/10. Bilateral swollen lymph nodes under arms....
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Dull headache in back of head and back of neck rated 7/10. Bilateral swollen lymph nodes under arms. Swollen, soft, non tender
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| 50 | 2021-02-24 | peripheral swelling |
Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling...
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Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling of lower legs and ankles
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| 50 | 2021-02-25 | swelling face |
Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflamm...
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Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
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| 50 | 2021-02-26 | peripheral swelling |
Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. C...
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Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. Could not raise arm without being in pain. Tired, headache behind the eyes, hard time breathing, chills (no fever) and dizziness. Still have headache and some dizziness and it has been a week and 2 days since the shot. Have not gone to the doctors. I have been treating myself with my inhalers and migraine medicine. Arm is better as far as soreness, but still have some bruising.
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| 50 | 2021-02-28 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 50 | 2021-03-01 | peripheral swelling |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-02 | lymph node swelling |
right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactabl...
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right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactable nurse (who is also the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the right arm, on 27Jan2021 13:15, at single dose, for COVID-19 immunization, at public health department. Medical history included hypertension (HTN), anxiety, depression, myalgia and penicillin allergy (PCN allergy). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included losartan; hydrochlorothiazide, triamterene (MAXZIDE); cetirizine; colecalciferol (VITAMIN D); escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccination. On 29Jan2021, the patient experienced right cervical and axillary lymphadenopathy. No treatment was given for the event. The patient was recovering from the event. The reporter assessed the event as non-serious.
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| 50 | 2021-03-02 | peripheral swelling, lymph node swelling |
Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. S...
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Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. Soreness down my arm.
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| 50 | 2021-03-02 | swelling, lymph node swelling |
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ...
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"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
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| 50 | 2021-03-03 | lymph node swelling |
Patient reported a large fluid filled sac with a marble size lump. Patient reported she worsened fo...
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Patient reported a large fluid filled sac with a marble size lump. Patient reported she worsened for approximated 4 days then slowly started getting better. She massaged regularly to help lessen the size. At 3 week follow up, we were able to confirm she had a swollen lymph node surrounded by fluid filled sac. Patient was confident it was getting better. I advised to run this past a physician but felt it would be ok.
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| 50 | 2021-03-04 | swelling face |
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recip...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They reported throat closing. They were treated by EMS on site with methylprednisolone. Vaccine recipient took their own epinephrine and diphenhydramine. They were transported to emergency department. They reported with an allergic reaction and face swelling. They were administered famotidine. During reexamination, the patient?s symptoms improved and they were discharged to home. Registered 03/03/2021 10:38 AM, Discharged 03/03/2021 1:41 PM.
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| 50 | 2021-03-05 | axillary mass |
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red...
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Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
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| 50 | 2021-03-05 | peripheral swelling |
Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction ...
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Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction when receiving flu shots. Fatigue, difficulty concentrating.
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| 50 | 2021-03-07 | lymph node swelling |
Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/...
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Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/wrist
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| 50 | 2021-03-07 | lymph node swelling |
Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection si...
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Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection site, the day of and up to at least 4 days after. Swollen lymph nodes under left arm (injection site arm) the day after and lasted at least 4 days.
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| 50 | 2021-03-08 | anaphylactic reaction | anaphylaxis, treated with epinephrine, |
| 50 | 2021-03-08 | lymph node swelling | Swollen lymph nodes in several places. |
| 50 | 2021-03-08 | peripheral swelling |
Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inabil...
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Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inability to raise arm and entire arm swollen. In addition to this on the first day of the adverse event flu like symptoms which lasted two days. Arm pain continues as at day four since adverse event started
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| 50 | 2021-03-09 | lymph node swelling |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-09 | peripheral swelling | Hands and feet swelling, Redness, Hives, Itchy Skin |
| 50 | 2021-03-09 | swelling face |
was fine at first then a little after 2 hours I started all of a sudden to get very light headed an...
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was fine at first then a little after 2 hours I started all of a sudden to get very light headed and dizzy....face felt very funny....swollen face and nausea along with slight fever and headache.
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| 50 | 2021-03-10 | lymph node swelling, lymph node pain |
On day 2 after vaccination I noticed generalized swelling under my left armpit & toward L breast. Sw...
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On day 2 after vaccination I noticed generalized swelling under my left armpit & toward L breast. Swollen & tender to touch. I am now on day 6 and swelling & tenderness r declining. On day 3 I noticed a swollen & tender lymph node on top of my L clavicle. One hour after my vaccination I had an issue with my vision that my eye doctor diagnosed as a visual migraine. I had never had one before.
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| 50 | 2021-03-10 | swelling |
I have had major swelling above my collarbone between my shoulder and neck on the left side, the sam...
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I have had major swelling above my collarbone between my shoulder and neck on the left side, the same side as I received my shot. It is tender to the touch. After four days, I can feel harder masses inside.
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| 50 | 2021-03-11 | lymph node pain, lymph node swelling |
Post first vaccine L axillary lymphadenopathy. Post #2-L sub acute thyroiditis with difficulty swal...
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Post first vaccine L axillary lymphadenopathy. Post #2-L sub acute thyroiditis with difficulty swallowing, pain and significant lymph node swelling that became worse over a week.
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| 50 | 2021-03-12 | swelling |
2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to ...
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2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to entire upper body and severe headache. Right front side a rib pushed out. Slept sitting straight up, could not put pressure on my spine at all. Spouse drove me to the chiropractor on 3/1/21 to have the rib adjusted. Six hours later my heart was literally pounding out of my chest for about a minute. Next day the swelling started to subside and can breathe again. Could lean back on my spine without any issues. Chiropractor on 3/3/21 and will go back next week. Intestines are still gurgling and 3/12/21 experienced diarrhea.
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| 50 | 2021-03-13 | anaphylactic reaction | Systemic: Allergic: Anaphylaxis-Medium |
| 50 | 2021-03-14 | lymph node swelling |
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes...
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Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
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| 50 | 2021-03-14 | lymph node swelling | Swollen, sore armpit lymph node same arm as injection Chills, fever, body aches |
| 50 | 2021-03-14 | peripheral swelling |
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to...
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Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
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| 50 | 2021-03-15 | peripheral swelling |
101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening inte...
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101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
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| 50 | 2021-03-15 | swelling |
20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Pati...
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20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Patient mildly swollen around eyes. VS Stable. IM Benadryl 50MG administered to right deltoid. O2 at 2L per NC administered. Improved for 10 minutes and then tingling and swelling returned. C/O of feeling lightheaded. Medicated with Epi pen to left thigh. Patient improved/stable and was sent via EMS to hospital for evaluation and treatment.
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| 50 | 2021-03-16 | lymph node swelling, lymph node pain |
Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination,...
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Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination, awoke with dizziness, nausea, chills. Diarrhea later in day. Starting 3 days after vaccine, painful and swollen and hard supraclavicular, Left axilla, cervical lymph nodes. Dizziness and nausea persist. Fatigue requiring 12 hours sleep. Paresthesias (tingling, "pins and needles"), both lower extremities, from toe to knee, unremitting, worst on day 2 after vaccination.
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| 50 | 2021-03-18 | lymph node swelling | Swollen painful lymphnode under armpit. |
| 50 | 2021-03-20 | peripheral swelling |
A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. N...
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A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. Now it looks more like a traditional rash. Also a little swollen. I felt a wave of dizziness. That has passed.
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| 50 | 2021-03-21 | lymph node swelling |
Starting around 11 the night of vaccine, started getting jabbing pains in right armpit area, very sw...
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Starting around 11 the night of vaccine, started getting jabbing pains in right armpit area, very swollen lymph nodes and weakness in arm. Today is Monday and still hasn't subsided. Have been icing and taking ibuprofen every 4 to 6 hours. Left work early at 12:30.
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| 50 | 2021-03-21 | swelling |
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor...
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collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
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| 50 | 2021-03-22 | lymph node swelling, axillary mass |
Swollen lymph nodes under my armpit. Once the swelling went down, I have two knots under my armpit ...
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Swollen lymph nodes under my armpit. Once the swelling went down, I have two knots under my armpit and a round patch on my right breast. I have regular mammograms once a year and I just completed one in October, 2020.
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| 50 | 2021-03-22 | peripheral swelling |
left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day ha...
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left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day has gone on it has gotten redder Called and spoke with a Teladoc doctor, said to take ibuprofen and ice, watch for 24/48 hours if gets redder or hot go and have it checked out for possible infection
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| 50 | 2021-03-24 | axillary mass |
After two days of fever and headache , I had some painful lumps on left underarm toward my left bre...
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After two days of fever and headache , I had some painful lumps on left underarm toward my left breast for three days. They disappeared for a couple of days and back again from yesterday. Its kind of burning in lumps with mild pain left side, arm, neck and back shoulder.
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| 50 | 2021-03-24 | swelling face |
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen...
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evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
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| 50 | 2021-03-27 | lymph node swelling | Fever, body aches, chills, swelling of lymph nodes |
| 50 | 2021-03-27 | peripheral swelling |
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod...
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Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
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| 50 | 2021-03-28 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, joint pain, muscle pain, nausea, swollen lymph n...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, joint pain, muscle pain, nausea, swollen lymph nodes, feeling unwell, tired, headache
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| 50 | 2021-03-28 | lymph node swelling |
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swo...
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On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
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| 50 | 2021-03-28 | oral herpes |
was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I s...
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was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I still have issues with mouth ulcers
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| 50 | 2021-03-28 | swelling |
couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib ...
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couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events "swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone" on an unspecified date, while the patient was not recovered from the rest of the events.
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| 50 | 2021-03-29 | lymph node swelling |
Itching at injection site (left arm); rash on left breast; rash on back (upper left side), swollen l...
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Itching at injection site (left arm); rash on left breast; rash on back (upper left side), swollen lymph nodes in left arm pit; bullseye around injection site (around 1 inch in diameter); sore throat; body aches; diagnosed with shingles on 3/24
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| 50 | 2021-03-29 | lymph node swelling |
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic no...
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Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
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| 50 | 2021-03-29 | oral herpes |
The next day I developed what I thought was a cold sore around the top part of the right side of my ...
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The next day I developed what I thought was a cold sore around the top part of the right side of my lip, then 3 days after that I had a mild shingles outbreak on the right side of my face.,
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| 50 | 2021-03-29 | white blood cell count increased |
3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was ...
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3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was walking to car after receiving her COVID-19 vaccine and a syncopal episode. Pt then had seizure like activity for approximately 1 min. Family states that she does have "stress seizures but is not on any anticonvulsants." Vital signs and blood sugar were assessed by onsite paramedic (AMR) and were within normal limits. Pt was then transported to hospital for further care." ED visit after Covid Vaccine 3/29/2021: HISTORY OF PRESENT ILLNESS: a 50 y.o. female who presents to the emergency department with history of bipolar and multiple psychiatric conditions including bipolar disorder. She presents today with episodes of ?seizure? and the desire to not speak to anybody. She has not been speaking to her husband since Friday and today while she was on the way out from getting a COVID vaccine fell to the floor and having shaking convulsing like episode. Husband states it lasted for 1 minutes and then resolved. He states that she has been unwilling to talk to him or medical staff and he does not know what is going on. He does affirm that she has been complaining about abdominal pain for the last 3 days and they did go to the hospital and have this worked up. He states that she has no known history of seizures and is not on any medications for this. CT head normal. Drug screen normal. Discharged to home.
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| 50 | 2021-03-30 | anaphylactic reaction |
Pt developed symptoms of anaphylaxis. Two doses of IM epinephrine were administered. 911 was called....
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Pt developed symptoms of anaphylaxis. Two doses of IM epinephrine were administered. 911 was called. The patient was taken to the hospital via ambulance.
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| 50 | 2021-03-30 | lymph node swelling, lymph node pain | Extremely swollen and painful lymph node under right arm |
| 50 | 2021-03-30 | lymph node swelling, swelling face |
Fever Chills Body ache Dry Cough Nasal Congestion Lymph nodes inflammation on the side of the injec...
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Fever Chills Body ache Dry Cough Nasal Congestion Lymph nodes inflammation on the side of the injection Tiredness Injection site pain Left cheek inflamation
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| 50 | 2021-03-30 | lymph node swelling |
Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from...
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Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from a contactable other hcp (patient). A 50-years-old- non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: El9265, Expiration Date: unknown) via unspecified route administration in arm left on 08Feb2021 12:30 as a single dose for covid-19 immunisation. Medical history included allergies: PCN and first dose of covid vaccine received on 18Jan2021 at 12:00. Prior to the vaccination patient was not diagnosed with covid-19. Since the vaccination the patient had not been tested for Covid-19. The patient's concomitant medications were not reported. On 09Feb2021 at 02:00 the patient experienced Grade 3 chills, body aches, left underarm lymphnode swelling and pain. Patient had not been treatment for the adverse event. The outcome of the event was recovered.
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| 50 | 2021-03-30 | lymph node swelling |
I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reacti...
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I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reaction. My right side lymph node became severely swollen disrupting my ability to breath and very itchy. This lymph node on the front side of the neck was protruding making it difficult to swallow. Used breathing inhalers. Immediately leaving the vaccination site my temperature went high and I had to take off my shirt while I began to sweat profusely. When I arrive home I checked my temperature it would fluctuate between 98.6 and 101. My vision became extremely blurred for two days. I could barely see so I had to lay down and close my eyes and rest as I thought I was losing my vision. These symptoms were adverse while standing. General feeling of be unwell.
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| 50 | 2021-03-30 | peripheral swelling, lymph node swelling |
blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; no...
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blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.
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| 50 | 2021-03-30 | swelling face | Eye and face swelling. Sore muscles, fatigue |
| 50 | 2021-03-30 | swelling face |
Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my in...
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Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my inner tighs and private area. Normal symptoms were sore arm and ache body. Bad headache
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| 50 | 2021-03-31 | lymph node swelling |
In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, heada...
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In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, headache, fever, swelling under armpit of same arm vaccine received.
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| 50 | 2021-03-31 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes (under arm-size of a grapefruit) 3 days ras...
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Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes (under arm-size of a grapefruit) 3 days rash (2nd day) tiredness (3 days) nausea (3 days) body aches (3 days) injection site redness/swelling (one day)
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| 50 | 2021-03-31 | lymph node swelling |
Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is...
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Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is day 5, I believe it is swollen lymph nodes. If not better I will go to Dr next week
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| 50 | 2021-03-31 | oral herpes |
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being f...
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AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/2020.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/22/21 Exposure: Home Exposure Symptoms:Fatigue,insomia,cold sore, headache, chills, runny nose, loss of taste/smell
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| 50 | 2021-03-31 | peripheral swelling | Noticeable swelling in left leg. |
| 50 | 2021-04-01 | lymph node swelling |
Swollen lymph node in underarm of left arm. Started shortly after 2nd dose of vaccine (Tuesday, 3/30...
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Swollen lymph node in underarm of left arm. Started shortly after 2nd dose of vaccine (Tuesday, 3/30/21) and is still present as of today (Friday, 4/2/21).
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| 50 | 2021-04-01 | lymph node swelling |
1st dose 3/9/21- I received the injection at ~6:30pm & these symptoms began on 3/9/21 at ~ 8:30pm & ...
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1st dose 3/9/21- I received the injection at ~6:30pm & these symptoms began on 3/9/21 at ~ 8:30pm & lasted for ~24 hours after receiving the vaccine ?> Slight swelling & soreness at injection sight (right arm), low grade fever, tiredness, slight nausea 2nd dose 3/31/21 - I received the injection at ~12:35pm & these symptoms began on 3/31/21 at ~2:30pm & are ongoing as of this reporting on 4/2/21 ?> Tightness, large swelling, & extreme soreness at injection sight (left arm), extreme fatigue, headache, severe joint pain all over body, dizziness & feeling faint, severe stabbing pain in left side on back at shoulder blade that became worse with deep breathing or sitting upright, gland swelling on neck
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| 50 | 2021-04-01 | peripheral swelling |
Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness ...
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Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness all over, and feelings of being intoxicated?slow to speak hard to gather my thoughts. Was taken to ER and given Benadryl shot and another IV medication. While in ER both my hands swelled.
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| 50 | 2021-04-01 | swelling | Tender/ soreness at injection site. Pain and swelling underarm area |
| 50 | 2021-04-02 | swelling | Swelling, lump (larger than golf ball) , pain in the armpit |
| 50 | 2021-04-02 | swelling | Pain at injections site, chills fever, intense back pain, swelling of back, headache |
| 50 | 2021-04-03 | lymph node swelling, lymph node pain |
Had very swollen lymph node on left side, bottom of neck, along my collar bone. Tender and sore, l...
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Had very swollen lymph node on left side, bottom of neck, along my collar bone. Tender and sore, like a pulled muscle but resolved itself within 36 hours. Very minor side effect, but wanted to report it for public health data gathering efforts.
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| 50 | 2021-04-04 | swelling |
My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention f...
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My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention from my armpit when I raised my arm. It looked different from other arm (completely). It was very swollen. No doctor visit. I took Advil after taking the pharmacist and she told me to take Advil. That helped with the swelling.
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| 50 | 2021-04-12 | swelling |
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ...
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pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
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| 50 | 2021-04-14 | white blood cell count increased |
50 yo female with no medical history known to our system presents with Inferior STEMI with ventricul...
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50 yo female with no medical history known to our system presents with Inferior STEMI with ventricular fibrillation cardiac arrest. Unknown initial downtime without CPR. Arrived by rescue squad and taken emergently to Cardiac Catheterization Lab, required mid-LAD stenting. Therapeutic temperature management (TTM), now rewarmed. Currently intubated on mechanical ventilation, on norepinephrine, poor neurological responses, consider neurology consult for brain evaluation/prognostic recommendations. There is a progress note written by ED RN on 4/12/21 that states family reports she had "her 2nd COVID shot 1 week ago," but per Wisconsin Immunization Registry, only 1 COVID vaccine is recorded.
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| 50 | 2021-04-18 | peripheral swelling |
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and sl...
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Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.
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| 50 | 2021-04-21 | lymph node swelling |
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h...
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*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
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| 50 | 2021-04-23 | swollen extremities |
4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4...
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4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4/19 - Emailed my Cardiologist about swollen ankles. Didn?t think about the vaccine as a potential cause. He scheduled an Echocardiogram for May. 4/20 to 4/22 - Edema is ankles and lower legs with pain on bottom left. Tried heat and elevation with no relief. 4/23 - Called Advice Nurse with recommendation to go to ER. ER determined a blood clot in left leg at the left posterior tibial vein measured at 6.3cm.
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| 50 | 2021-04-28 | anaphylactic reaction |
Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up...
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Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up to back of throat. Resting heart rate of 133 BPM at triage in ER. Severe coughing which caused vomiting. Slight pink flushing of nose and cheekbones 30 minutes after shot, after leaving vaccination site, with no adverse reaction.
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| 50 | 2021-04-30 | anaphylactic reaction |
Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Yea...
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Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87306), via an unspecified route of administration, administered in left arm on 25Mar2021 at 21:27 (at the age of 50 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced Anaphylactic reaction. The patient visited emergency room on 25Mar2021 and and was released from the emergency room on 26Mar2021. The patient received treatment for the events. Caller stated from her understanding from her doctor she was not anaphylactic to anything in the shot but she had an anaphylactic reaction. Caller stated she wanted know since the vaccine is federally regulated and mandated and she has health insurance but her (Services name) and deductible is high and her being anaphylactic to the shot and receiving care and now receiving bills does Pfizer offer any help with that. Anaphylactic reaction: Caller stated this ended the next morning because it was overnight when she was released from the hospital. Caller clarified she was brought to the emergency room and was released from the emergency room. Treatment: Caller stated she was provided medication at the site of the (Name) and then put in an ambulance and was given medication then transported to the hospital. Caller stated the COVID vaccine she received was the first dose and last dose. Caller stated the physician office was not open and the hospital she wanted to go to was approximately 30 minutes away and she was transported to the nearest hospital to the facility location. The patient did not undergo any lab tests and procedures. The outcome of the events was recovered on 26Mar2021.
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| 50 | 2021-04-30 | swelling, peripheral swelling |
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i...
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A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
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| 50 | 2021-05-07 | peripheral swelling |
Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and ...
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Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and constant abdominal pain; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:00 (at the age of 50-years-old) (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation. Medical history included weight abnormal, Pituitary tumor extracted, known allergies_PCN. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 for Covid-19 immunisation on 30Mar2021 at 50-years-old. (Product: Covid 19, Brand: Pfizer, Lot Number: ER8727, Lot unknown: False, Administration Date: 30Mar2021, Administration time: 01:00PM, Vaccine location: Left arm, Dose Number: 1). On 08Apr2021 16:45, the patient experienced Fever 103, total and severe body ache, chills, vomiting, swelling of hands, dizziness, terrible and constant, abdominal pain. I have O Negative Blood and high percentages of Neanderthal DNA (more than 97% of population). The events were assessed as serious (disability). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 08Apr2021 Fever 103. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.
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| 50 | 2021-05-09 | anaphylactic reaction |
anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilatio...
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anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilation, heart palpitations, chest tightening/difficulty breathing
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| 50 | 2021-05-09 | lymph node swelling |
Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused verti...
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Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused vertigo for a short time the next morning. Neck lymph node swollen for 3 days. Armpit is still swollen. Aches, joint pain, fatigue, fever 101 have resolved. Nausea continues.
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| 50 | 2021-05-12 | anaphylactic reaction |
Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was re...
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Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was retreated with EpiPen. Also given Benadryl by RPh on duty. given IM Benadryl by EMT. Throat swelled up and pt has trouble breathing
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| 50 | 2021-05-18 | swelling face |
Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, to...
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Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; This is a spontaneous report received from a contactable female consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration on 27Mar2021 09:00 first dose single for covid-19 immunisation. Medical history included fatty liver, diverticulitis, migraine and cigarette smoke. The patient concomitant medications were not reported. The patient previously took sulfonamide (Sulfa / FQ drugs) allergy to sulphonaminde and histamine allergy to histamine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination of antioxidant Green Tea and Liver Cleanse Tea and Vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Tingling and Swelling of lower face, lips, tongue, throat on 28Mar2021 02:30 AM. Patient visited the emergency room. As per the reporter seriousness criteria for the events swelling of lower face, lips, tongue, throat was medically significant. Patient received treatment of Benadryl-self-administered prior to ER. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430745 similar report from same reporter
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| 51 | 2020-12-31 | lymph node pain, lymph node swelling |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2020-12-31 | lymph node swelling |
on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling w...
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on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling weel. on 12/31 reported that the lymph nodes near clavicle have now swelled. The other lymph nodes have not ceased being swollen.
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| 51 | 2021-01-04 | anaphylactic reaction | Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting |
| 51 | 2021-01-04 | lymph node swelling |
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav...
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Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
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| 51 | 2021-01-04 | swelling face |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | swelling face |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-05 | lymph node pain, lymph node swelling |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-06 | lymph node swelling |
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ...
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had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
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| 51 | 2021-01-07 | lymph node swelling |
injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site a...
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injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.
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| 51 | 2021-01-07 | lymph node swelling |
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,...
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Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
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| 51 | 2021-01-07 | swelling face |
Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl an...
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Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330
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| 51 | 2021-01-08 | lymph node swelling, swelling |
Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain...
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Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain and swelling of deltoid
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| 51 | 2021-01-08 | lymph node swelling | Myalgia SOFT TISSUE SWELLING RIGHT AXILLA, SWOLLEN UPPER ARM; Narrative: |
| 51 | 2021-01-09 | lymph node swelling |
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm...
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Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
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| 51 | 2021-01-09 | lymph node swelling |
Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis ar...
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Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis area. General headache.
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| 51 | 2021-01-10 | lymph node swelling |
36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node ...
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36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node in armpit of left arm
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| 51 | 2021-01-10 | peripheral swelling, axillary mass |
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac...
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Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
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| 51 | 2021-01-10 | swelling face |
Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms ...
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Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.
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| 51 | 2021-01-10 | swelling |
Immunization received at 3pm no reaction immediately. Next morning I woke up with acne type lesions...
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Immunization received at 3pm no reaction immediately. Next morning I woke up with acne type lesions on my face and a large elongated swollen area on my back. My face cleared up but I had to go to the MD and have the back wound incision and drainage.
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| 51 | 2021-01-11 | anaphylactic reaction |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | lymph node pain, lymph node swelling |
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ...
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Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
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| 51 | 2021-01-11 | lymph node swelling, lymph node pain | Swollen under the axial lymph node with pain |
| 51 | 2021-01-11 | lymph node swelling |
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy...
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Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
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| 51 | 2021-01-11 | lymph node swelling |
10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve...
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10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
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| 51 | 2021-01-11 | swollen extremities |
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa...
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Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
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| 51 | 2021-01-11 | peripheral swelling |
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ...
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Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
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| 51 | 2021-01-11 | swelling face |
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pai...
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Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-12 | lymph node swelling |
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min...
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No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
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| 51 | 2021-01-12 | peripheral swelling |
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain...
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Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
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| 51 | 2021-01-13 | lymph node swelling, swelling |
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left a...
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Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
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| 51 | 2021-01-13 | lymph node swelling |
Axillary lymphadenopathy with swelling extending to left breast. Left Scilla lymph node size of gol...
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Axillary lymphadenopathy with swelling extending to left breast. Left Scilla lymph node size of golf ball
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| 51 | 2021-01-13 | lymph node swelling |
1/2/2021 - Went for mammogram. Abnormal reading on left breast 1/8/2021- Follow up mammogram. Left b...
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1/2/2021 - Went for mammogram. Abnormal reading on left breast 1/8/2021- Follow up mammogram. Left breast dense tissue. Had ultrasound- lymph node under left armpit, 6mm. Will have ultrasound again in 6-8 weeks, Employee's MD stated that if the lymph node is reduces in size - then it is probably due to the covid shot.
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| 51 | 2021-01-13 | lymph node swelling |
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea...
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Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
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| 51 | 2021-01-13 | peripheral swelling |
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g...
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Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
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| 51 | 2021-01-13 | peripheral swelling |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-14 | lymph node swelling |
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r...
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On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
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| 51 | 2021-01-14 | swelling face |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-17 | lymph node pain |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-18 | lymph node swelling |
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we...
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9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
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| 51 | 2021-01-18 | swelling face, peripheral swelling | Systemic: Mild swelling on right side of the face and legs |
| 51 | 2021-01-20 | anaphylactic reaction | Systemic: Anaphylaxis |
| 51 | 2021-01-20 | swelling face, lymph node swelling |
12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular ...
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12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular type eruption on nose. Fever/chills persisted through night, followed by 16hr N/V and worsening of eruption- vesicular/pustular on nose, then with subsequent right facial swelling.
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| 51 | 2021-01-21 | swelling face | Minor Face and Throat swelling. Irregular eye lid movement. Lips num and felt twisted. |
| 51 | 2021-01-23 | lymph node swelling |
By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit a...
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By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit as well as soreness at the injection site (which started hours earlier). On 1/24/20, chills and extreme fatigue continued along with dull headache, lack of appetite, and general feeling of unwellness. Temperature at 3:30pm was 101.2F.
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| 51 | 2021-01-25 | lymph node pain, lymph node swelling |
diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; F...
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diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.
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| 51 | 2021-01-26 | peripheral swelling, swelling face |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-27 | lymph node swelling |
after received the pfizer vaccine. Within a day, I have a swollen Lymph Nodes on the side of the arm...
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after received the pfizer vaccine. Within a day, I have a swollen Lymph Nodes on the side of the arms that Vaccine was injected. It hurts when close left arm to my body.
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| 51 | 2021-01-27 | swelling |
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; musc...
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rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
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| 51 | 2021-01-28 | swelling |
Angioedema within 5 minutes, epinephrine 0.3mg IM given at clinic site, transferred to emergency roo...
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Angioedema within 5 minutes, epinephrine 0.3mg IM given at clinic site, transferred to emergency room, given famotidine and diphenhydramine, methylprednisolone inj @ 1333. angioedemia resolved within 30 minutes from interventions.
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| 51 | 2021-01-28 | lymph node swelling |
Started with body aches about 14 hours after injection progress to severe joint and bone aches espec...
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Started with body aches about 14 hours after injection progress to severe joint and bone aches especially in hands and feet . Stabbing random headaches , fever 101, chills, sweating these symptoms lasted about 24 hours . Then about about 36 hours I woke up in the morning with swollen lymph nodes under left arm very painful. All other symptoms have gone but swollen lymph nodes are persisting current time since dose is about 48hrs.
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| 51 | 2021-01-28 | lymph node swelling |
severe headache and fatigue began about 3 p.m. on 1/21/21 (the day after vaccine administered). I w...
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severe headache and fatigue began about 3 p.m. on 1/21/21 (the day after vaccine administered). I went to bed early and slept later than usual and after about 9 1/2 hours of sleep, the headache and fatigue were only very minimal. On 1/22/21 when I woke up I had an enlarged lymph node under my arm about 2 inches in diameter. The lymph node was enlarged until 1/27/21
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| 51 | 2021-01-28 | lymph node swelling |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | swelling face |
Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapu...
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Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well. Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
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| 51 | 2021-01-31 | peripheral swelling |
1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and ...
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1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.
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| 51 | 2021-02-02 | peripheral swelling |
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de...
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**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
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| 51 | 2021-02-03 | peripheral swelling |
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell...
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This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
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| 51 | 2021-02-03 | swelling face |
She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her f...
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She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
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| 51 | 2021-02-04 | lymph node swelling |
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o...
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Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
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| 51 | 2021-02-04 | lymph node swelling |
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj...
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02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
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| 51 | 2021-02-04 | lymph node swelling |
Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the sid...
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Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the side of injection ( size of a ping pong ball)
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| 51 | 2021-02-05 | lymph node swelling | Low grade fever and underarm swelling/soreness Fever lasted around 6 hours |
| 51 | 2021-02-07 | lymph node swelling |
Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on r...
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Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on rt. side (injection side), no treatment given at this time, Pain continues will see MD. Pain noted under armpit when lying on that side. Visible swelling of armpit and rt. chest area present.
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| 51 | 2021-02-07 | peripheral swelling | Swelling and very painful arm. The size of a grapefruit. Fever, headache, weakness and body aches |
| 51 | 2021-02-07 | swelling |
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to ...
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Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
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| 51 | 2021-02-08 | lymph node swelling, swollen extremities |
Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elb...
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Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elbow to neck to scapula. Started about 12hours after injection (woke me at 4:00am). Then over the next several hours developed fever up to 101.5, ibuprofen reduced only to 100.4. This cycle continued through the following day, when temp peaked at 102.2 around 48hr post-injection. Added Tylenol to the ibuprofen, temp then decreased to 100.4. Woke the third day with un-medicated temp between 99-100 all day, but L axillary lymph nodes now swollen. Spent all 3 days on couch, resting and pushing fluids. No GI symptoms at all. Day 4 - Temp normal, but slightly dizzy. Pain and some edema from elbow to scapula to neck continued throughout and still continues now. Axillary lymph nodes still swollen and sore. Some nasal congestion, still a bit dizzy. Never had any pain (just tender to touch) at the actual injection site. Also, I never had any symptoms at all with the first injection. I see nowhere else to put this - I received the injection at my workplace.
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| 51 | 2021-02-08 | swelling |
Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching...
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Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching and showing some raised red hives on arms and scalp and a little on the back. we administered Benedryl 50mg IM and within about 10 minutes itching decreased and no additional symptoms have arrisen
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| 51 | 2021-02-09 | lymph node swelling, swelling |
Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base ...
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Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 51 | 2021-02-09 | lymph node swelling |
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under ...
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Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
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| 51 | 2021-02-10 | lymph node pain |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-10 | peripheral swelling |
LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, s...
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LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, still have pain and swelling 5 weeks after shot
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| 51 | 2021-02-11 | swelling |
Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph n...
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Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph node swelling.
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| 51 | 2021-02-14 | anaphylactic reaction, swelling face |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
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| 51 | 2021-02-14 | lymph node swelling | enlarged lymph node r axilla, no rash, no face/mouth swelling, afebrile, no swelling of extremity |
| 51 | 2021-02-14 | swollen extremities, white blood cell count increased |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-14 | swelling |
Interaction with derma-fillers- no medical attention needed. Ice applied to the sore -mildly swollen...
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Interaction with derma-fillers- no medical attention needed. Ice applied to the sore -mildly swollen areas. Soreness subsided within 48 hours of onset.
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| 51 | 2021-02-15 | peripheral swelling |
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti...
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At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
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| 51 | 2021-02-16 | peripheral swelling, lymph node swelling |
General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of ...
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General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of armpit lymph node. And later entire arm. Very painful, tender, sore and with restricted movement. Home medical visit Sat and Monday with Doctor. Ice/heat, liquids, Ibuprofen compression sleeve and elevation
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| 51 | 2021-02-17 | swelling, lymph node swelling |
Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into...
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Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into my jaw is where it's hurting. This usually comes with a migraine, but I don't have one today. It's just odd because I've never had this before, all the symptoms all at once. I've noticed under my left arm pit on occasions, sometimes when I'm laying at night feel swollen and in my groan as well. I have had some weird symptoms. I do get chills of and on but not at this very moment. My left ear has became hurting where the jaw pain is. I have to have my ears cleaned every so after so not sure if that has to do with my pain going on. I saw the ENT on December 30 and going to see them again on February 24th.
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| 51 | 2021-02-21 | lymph node swelling |
On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above m...
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On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above my left clavical bone. My neck felt and under my chin felt sore and tender. It is day 9 and I still have the swollen nodes, soreness and tender feeling in neck, shoulder and chin.
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| 51 | 2021-02-21 | lymph node swelling | The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone. |
| 51 | 2021-02-21 | lymph node swelling |
Enlarged lymph nodes on left and right side of armpits and both breasts. The left side enlargement ...
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Enlarged lymph nodes on left and right side of armpits and both breasts. The left side enlargement was very visible to the naked eye and looked to be as large as a tennis ball. Both breasts where swollen and tender/sore. Right side enlargement of armpit as not as large (maybe the size of a golf ball).
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| 51 | 2021-02-21 | peripheral swelling |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-23 | lymph node swelling |
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy ...
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Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt. Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
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| 51 | 2021-02-24 | peripheral swelling, swelling face |
1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to th...
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1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to the size of my hand. The following day, I started getting hives, SOB, and my sinus swelled up, face and extremities. I took Benadryl and went to Urgent Care. Urgent Care put me on medication; vertigo, allergic reaction and sinus infection. Start taking Famotidine, Hydroxyzine-pamoate, prednisone. Followed up with PCM; benadryl Sinuses are still swollen, facial parts still swollen. Going to follow up with PCM I take a nebulizer. That medicine, the albuterol, inhaler Prevail.
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| 51 | 2021-02-25 | peripheral swelling |
At the vaccine administration location, patient experienced the following symptoms: tightness in che...
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At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
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| 51 | 2021-02-25 | swelling face |
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w...
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About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
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| 51 | 2021-02-26 | peripheral swelling |
Patient had immediate swelling to left hand (vaccine received in left arm). Bilateral grip strength ...
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Patient had immediate swelling to left hand (vaccine received in left arm). Bilateral grip strength equal, pulses equal bilaterally, ROM equal bilaterally. Patient is obese so it was difficult to detect swelling but her spouse stated her left hand "looked a little swollen." She was assessed by paramedics and given Benadryl 25 mg.
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| 51 | 2021-02-27 | lymph node pain, lymph node swelling |
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after...
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Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
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| 51 | 2021-02-28 | lymph node swelling, swelling |
I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under...
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I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under neck lymph nodes got swollen. I'm still exp swelling top clavicle lasting 2 months. I did see my PCP was told it was inflammatory response.
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| 51 | 2021-03-01 | anaphylactic reaction |
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our...
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Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
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| 51 | 2021-03-01 | lymph node swelling | Thickening of lymph node in left axillary. |
| 51 | 2021-03-02 | lymph node swelling, peripheral swelling, lymph node pain |
patient had pain in the arm that she received the vaccine; patient had pain in the arm that she rece...
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patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been obtained.
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| 51 | 2021-03-02 | lymph node swelling |
The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move ...
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The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move or sleep.
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| 51 | 2021-03-03 | peripheral swelling |
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz...
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Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
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| 51 | 2021-03-04 | lymph node swelling | Headaches, underarm glands swollen, body aches, soreness, redness of arm, fever near area |
| 51 | 2021-03-05 | lymph node swelling |
swollen lymph nodes under right arm week after first injection did not get better second injection...
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swollen lymph nodes under right arm week after first injection did not get better second injection was given in left arm a week after swollen lymph nodes underarm left arm now two weeks out have swollen lymph nodes everywhere neck behind ears back groin inner thighs
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| 51 | 2021-03-07 | peripheral swelling |
Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be pr...
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Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be productive for 5 days.
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| 51 | 2021-03-07 | swelling |
02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately ...
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02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately at the site, ct felt neck swell 'like a balloon', monitored x 30 min, RNs at clinic determined not an anaphylactic reaction. PHN at site recommended after 24hrs to take antinflammatory and warm pack on site. Neck sensation continued x couple of days, referred to PCP for evaluation.
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| 51 | 2021-03-08 | lymph node swelling |
Dose was given at 2:20pm. On March 6th By 10pm tiredness began Slept for 11 hours Woke up on the 7th...
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Dose was given at 2:20pm. On March 6th By 10pm tiredness began Slept for 11 hours Woke up on the 7th with chills which lasted on and off as doses of tylenol wore off Muscle aches in arms and legs all day. Slept throughout the day feeling as if I could not get fully awake. By 10pm on the 7th,the night after the shot, I was back in bed. Woke up on the 8th feeling rested, no more body aches or chills....but a lump had appeared over night in my left armpit...i assume a swollen lymph node as it is on the side of the injection. Today is the 9th and the lymph node is still swollen.
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| 51 | 2021-03-08 | oral herpes |
Initial 48 hour period showed little to no reaction. Then chills and fever of 101 followed by more ...
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Initial 48 hour period showed little to no reaction. Then chills and fever of 101 followed by more chills and low grade fluctuating fever going on over 48 hours. The unusual event is that this reaction occurred 8 days after vaccination beginning on 3/7/21. Has not resolved completely yet as of 3/9/21. Because of the delay, I took a covid19 pcr test which was negative.
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| 51 | 2021-03-09 | lymph node pain, lymph node swelling |
The next day after I received the Covid 19 vaccine, my lymph node under my left arm ( the arm in whi...
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The next day after I received the Covid 19 vaccine, my lymph node under my left arm ( the arm in which I received the vaccine ) swelled to about the size of a softball, and was very tender for 3-4 days in duration.
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| 51 | 2021-03-09 | swelling face | I had bad hives allergy reacción and swollen face , |
| 51 | 2021-03-09 | swelling |
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with...
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Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
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| 51 | 2021-03-11 | lymph node swelling |
My left arm where the shot was administered, my underarm developed a huge swollen lymph node that la...
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My left arm where the shot was administered, my underarm developed a huge swollen lymph node that lasted for about 4 days before the swelling went down.
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| 51 | 2021-03-11 | lymph node swelling |
approx 18 hours after vaccine admin: chills, tiredness and body aches - rest, alternating ibuprofen,...
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approx 18 hours after vaccine admin: chills, tiredness and body aches - rest, alternating ibuprofen, tylenol - a nap resolved the tiredness, medication did not help the body aches or chills; symptoms resolved by approx 28 hours after admin; approx 48 hours after admin, swelling of lymph nodes in right armpit - tried ice, ibuprofen - did not resolve the condition or discomfort, however, heat has helped the discomfort, has not resolved as of 65 hours post vaccination
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| 51 | 2021-03-14 | lymph node pain | Loss of appetite, fatigue, nausea, fluid collection in elbow, tender lymph nodes in left side neck. |
| 51 | 2021-03-14 | lymph node swelling |
swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This...
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swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 51 | 2021-03-15 | swelling face |
3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burni...
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3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burning sensation. The burning stopped with the fir dose of Benadryl 25mg (which I took every 8 hours for 3 additional doses) The swelling eventually decreased after 3-4 days.
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| 51 | 2021-03-16 | oral herpes |
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi...
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1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
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| 51 | 2021-03-17 | oral herpes | Mouth cold sore appeared (previous infection) |
| 51 | 2021-03-17 | peripheral swelling |
Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swoll...
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Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swollen. Headache began about 9 pm on 3/16 and is still present on 3/18. 3/17 body aches, chills, sweats, worse headache.
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| 51 | 2021-03-17 | swelling |
I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vacc...
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I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vaccine and look forward to the second injection.
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| 51 | 2021-03-18 | anaphylactic reaction |
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 mi...
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Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
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| 51 | 2021-03-18 | peripheral swelling |
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva...
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Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
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| 51 | 2021-03-19 | lymph node swelling | Swollen lymph nodes ( both) at jawbones |
| 51 | 2021-03-19 | peripheral swelling |
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm...
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Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
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| 51 | 2021-03-21 | swelling face |
Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very...
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Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very itchy and a little swollen, no redness. I felt achy and tired for rest of day. On 3/21/21 I awoke and felt very, very tired and unwell. Became incredibly nauseous, dizzy at times and had a very strong headache which lasted all day, chills, face was slightly swollen, muscle and joint aches. Injection site still hurt.
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| 51 | 2021-03-22 | lymph node pain, lymph node swelling |
Swollen lymph nodes in right side of neck. In front of ear. Per local Emergency Room, CT scan showed...
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Swollen lymph nodes in right side of neck. In front of ear. Per local Emergency Room, CT scan showed everything ok. Visible swelling and tender to touch for 4 weeks now.
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| 51 | 2021-03-22 | lymph node pain |
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ...
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Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
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| 51 | 2021-03-23 | lymph node swelling |
pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hou...
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pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hour after vaccine, denied any difficulty swallowing, sob or chest pain(reported she had vaccine at other pharmacy and was fine after waiting 15 min.
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| 51 | 2021-03-23 | peripheral swelling |
Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and h...
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Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and hurts
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| 51 | 2021-03-24 | lymph node swelling |
I experienced fever, joint pain, body aches from 12-36 hours after the injection. I experienced a sw...
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I experienced fever, joint pain, body aches from 12-36 hours after the injection. I experienced a swollen lymph node under the arm injected with the vaccine. Tylenol used for pain and fever.
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| 51 | 2021-03-24 | lymph node swelling |
Extremely swollen lymph nodes near left collarbone. Noted that injection was given relatively high ...
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Extremely swollen lymph nodes near left collarbone. Noted that injection was given relatively high on arm.
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| 51 | 2021-03-28 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine Swollen lymph nodes (lymphadenopathy) left/right armpit. Left predo...
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Pfizer-BioNTech COVID-19 Vaccine Swollen lymph nodes (lymphadenopathy) left/right armpit. Left predominantly.
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| 51 | 2021-03-28 | swelling face |
Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills...
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Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills, Sweats, Joint Pain, Nausea, Throat felt swollen, Shallow Breathing, Swelling in Face (Left side of face for 48 hours), Weakness
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| 51 | 2021-03-28 | swelling |
Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in ...
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Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in the underarm area. As of Monday, it is slightly less tender and swollen but still has tenderness.
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| 51 | 2021-03-28 | swelling |
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter devel...
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Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling, hot to touch, sheering pain size half of a grapefruit. Tingling in right hand. Sought medical help.
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| 51 | 2021-03-29 | anaphylactic reaction |
Patient developed anaphylactic reaction after vaccination. Patient pretreated with 50 mg of benadry...
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Patient developed anaphylactic reaction after vaccination. Patient pretreated with 50 mg of benadryl and 3 hours after vaccination had to take 50 mg more of Benadryl due to throat closing up, hives and increased heart rate. Went to physician assistant and received 50 mg Benadryl and medrol dose pak. Patient also used albuterol MDI. Symptoms resolved 6 hours after vaccination. Continued to have a headache, injection site pain and fatigue for 24 hours.
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| 51 | 2021-03-29 | lymph node swelling |
Swelling in right armpit - initially swollen area was approximately 4 inches in diameter Diagnosed b...
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Swelling in right armpit - initially swollen area was approximately 4 inches in diameter Diagnosed by an urgent care physician as a swollen lymph node Swelling has slowly decreased; still present today - swollen area now approximately 1 inch in diameter
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| 51 | 2021-03-29 | swelling face |
The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 d...
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The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 days. My eyes, nose, cheek and lips were swollen. I also had, body aches, chill and a headache. I took Motrin, slept most of the day. The following day/day 2 most of the swelling was gone and my flu symptoms were gone. By day three all of the swelling was gone. I did not go to the doctor.
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| 51 | 2021-03-29 | swelling, lymph node swelling |
Soreness around site of shot that increased into moderate pain with mild swelling in upper arm and a...
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Soreness around site of shot that increased into moderate pain with mild swelling in upper arm and arm pit. Slight swelling of under arm lymph node that has resided, but the soreness persists.
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| 51 | 2021-03-30 | lymph node swelling, peripheral swelling |
Patient received second dose of Pfizer BioNTech COVID Vaccine on 2/23/21. On 2/25 patient called PCP...
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Patient received second dose of Pfizer BioNTech COVID Vaccine on 2/23/21. On 2/25 patient called PCP office expressing swollen & painful lymph node to left clavicle/shoulder area . Same arm as injection. Pain 2-3/10. Pt denied any other symptoms. Managed with warm compress, however on 3/26/21 patient went to the emergency room with complaint of continued swelling and redness on left arm. Ultra sound of the upper extremity showed short segment Nonocclusive thrombus in the left proximal subclavian
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| 51 | 2021-03-30 | lymph node swelling |
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with...
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Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 51 | 2021-03-30 | lymph node swelling | swollen lymph nodes in right arm pit area |
| 51 | 2021-03-30 | swelling face |
2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump o...
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2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump on my jaw I looked in the mirror and my left side of my neck was flame red then it spread to the front of my neck then it spread to the right side. It started moving down to my chest. The rash started getting raised hives that looked like they were turning into blisters.. It was horribly itchy but the worst part is it felt like I had been scorched. Luckily I had antihistamines here on hand that eventually thank God turned it around. The next day on Monday I was in almost a comatose sleep like anesthesia I didn't know what day it was. Then on Tuesday my right side of my face went numb and felt like it was drawing down. My speech was slurry I was drooling out of my right side and I was having glitches with my memory. Today I'm still having speech difficulties gait problems and I'm hearing roaring in my ears. This is so terrifying.
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| 51 | 2021-03-31 | lymph node pain |
1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surf...
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1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surfaced within hrs. Massive headache - affected peripheral vision, nausea, body aches, hot, and chills, mild dry heaves, vomitted once, weak & slightly faint, dizzy , sharp painful lymph nodes (left collar bone, Left underarm area, side of left breast, slight burning sensation, Thursday woke up with pain in back of knees, back, neck and head, in bed Wed evening through Friday, touch of diarrhea, bowel movement seemed to slightly alleviate headache, touch of stomach gas, back to work Monday, Tuesday woke up with massive headache again unable to lift head from bed, nausea, & chills unable to go to work. Wednesday back to work - got home felt fatigued slept from 5pm to 6:45 am.
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| 51 | 2021-03-31 | lymph node swelling | Swollen armpit lymph nodes, sensitivity and left arm pain |
| 51 | 2021-04-01 | lymph node pain |
25 hrs after injection I was tired, muscle and joint aches, low grade fever, slight stomach upset an...
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25 hrs after injection I was tired, muscle and joint aches, low grade fever, slight stomach upset and had moderate lymph node pain( below armpit of injection arm).
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| 51 | 2021-04-01 | lymph node swelling, lymph node pain |
SWOLLEN LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE PAIN ON INJECTION SITE. HEADACHE. BODY ACHES....
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SWOLLEN LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE PAIN ON INJECTION SITE. HEADACHE. BODY ACHES. SOME CURRENT RESIDUAL SWELLING AND SORENESS OF LYMPH NODE.
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| 51 | 2021-04-01 | peripheral swelling | itching of hands and feet, swelling of hands and feet, shortness of breath |
| 51 | 2021-04-01 | peripheral swelling |
I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was ext...
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I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was extremely tired, but other than that no adverse reaction. I received my second shot on March 19th, my arm again swollen and sore, and I could barely keep my eyes open the rest of the day. On 3/20/21, I woke at 8:30, feeling like I had hardly slept at all even though I had slept for 9 hours. I woke up wheezing, which led to me coughing and chills but no fever. The exhaustion I had felt after the first shot, was nothing compared to this. I thought it would go away, but it didn't. I also noticed a lot for fluid retention in my lower legs and stomach area. When I got on the scale, in the 20 days from the 1st shot til the day after the second shot I had gained 20 pounds of fluid. I was stunned. I could barely do a simple task, then I would have to sit down to rest for a minute, and would immediately fall asleep for 2 to 3 hours. I went to my doctor's on 3/22/21. They did a covid test, it was negative. The doctor said I was definitely wheezing and gave me the only sample inhaler that they had in stock Anorro to try to open up my airways. After a week, I was still having the issues, went back to doctor on 3/29/21 This time they perscribed 12 days of taper steroids. I am on day 4. I also received a referral to see a pulmonary specialist. I am still dealing with the exhaustion, wheezing and cough.
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| 51 | 2021-04-01 | swelling face |
very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. V...
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very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. Very irritated and painful. Healing, but still evident today.
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| 51 | 2021-04-02 | lymph node swelling, lymph node pain |
Sore and swollen left axillary lymph node x 3 days, headache x 3 days, low grade fever x 12 hours, d...
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Sore and swollen left axillary lymph node x 3 days, headache x 3 days, low grade fever x 12 hours, dizziness and nausea x 12 hours, fatigue x 3 days
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| 51 | 2021-04-02 | peripheral swelling, swelling, lymph node swelling |
headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits ...
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headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; itching on both of her feet; red circle where she got the injection. It was the size of a dime and only there on 28Jan2021; arm that she got the vaccine in got very large; Swelling in the upper breast area/swelling in her upper chest; Swelling and pain in the neck/Neck pain; Swelling and pain in the neck/Neck pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 as single dose for covid-19 immunization.Medical history included menopause or has been through menopause, Flu shot, hormonal issues, she started with a bizarre virus, whole lymph node response; It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting, she had a little infection and inflammatory markers come back positive. Concomitant medication included probiotics, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took flu for influenza immunisation and experienced peripheral swelling, tetanus vaccine for immunisation, amoxicillin, and experienced drug hypersensitivity, flagyl [metronidazole] and experienced drug hypersensitivity. The patient reported adverse events associated with her first Pfizer COVID vaccine shot. She experienced swelling in the upper breast area, swelling and pain in the neck, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared. She thought on whether to get the second shot of the vaccine considering these side effects since her doctor did not know why this was happening according to her. She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It was strange. She did not read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thought it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she does not know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her armpits started itching like crazy. It was severe itching and swelling in her armpits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It was both armpits. The night of the shot she had a lot of neck pain and she thought it was probably the lymph nodes in the back of her neck. That has lasted and was slowly diminishing. The patient was not planning on getting it. There was an agency that for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. He was given a batch for the residential agency but had extras. She was going through menopause or has been through menopause. She has hot flashes and has hormonal issues. The first week of December she started with a bizarre virus. She got tested for COVID and it was negative. It was not a rapid test it was a sendoff. Through that illness she had a whole lymph node response which was super unusual. The doctor said it was really strange. It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting. She had recovered from that and was back to normal. Four days before she got the shot all of that had resolved. Prior to getting the vaccine she had been tested for Lymphoma and it was negative, and she had a little infection, and her white blood count was normal. She had inflammatory markers come back positive prior to getting the vaccine. She went to the doctor on 27Jan2021 and asked if she should get the shot. The doctor said to do it because if she got COVID it would be worse. She was going to have a follow up with doctor for the ongoing stuff and he might do more test. Never in the course of any of that did she have itching armpits or swelling that lasted all this time. She never had chest swelling. The shot in the arm and it moved across her chest. It was reported that, back in the 90's, in 1993 or 1994, flu shots caused her arm to swell really large and stayed swollen for three months. That was the last three flu shots she got in the 90's. Then the doctor said not to get them. No one said why. She doesn't have allergy to eggs or anything that she knows to cause that. She has gotten all other vaccines and tetanus within the last 10 years. Her arm would kind of react but not like that. It went away in a reasonable amount of time. She didn't get a fever. The patient does not have NDC, lot and expiry for flu shots, other vaccines or tetanus to provide. When her kids were younger, they all had to be vaccinated for rabies. She did not have any reaction at all with those vaccines. She has allergies to antibiotics. She does not have lot numbers, NDC, or expiry for the antibiotics she was allergic to. She was allergic to Amoxicillin, Flagyl, Doxycycline, and Sulfa drugs. She has allergies to adhesive and contrast dye. No food allergies. She has allergies to dog and other environmental allergies. She does not take any medications for any of that. She has never had any anaphylactic shock of any kind. It has always been hives. The patient experienced swelling in the upper breast area/swelling in her upper chest, swelling and pain in the neck/neck pain, swelling and pain in the neck/neck pain, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/it is both armpits, arm that she got the vaccine in got very large, itching on both of her feet, red circle where she got the injection. It was the size of a dime and only there on 28jan2021, headache, arm started aching and the lymph nodes in her arm are still swollen. Outcome of the events Swelling in the upper breast area/swelling in her upper chest and arm that she got the vaccine in got very large was recovering, outcome of the events Swelling and pain in the neck/Neck pain, Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits, itching on both of her feet and red circle where she got the injection. It was the size of a dime and only there on 28Jan2021 was recovered and outcome unknown for other events. Information on the lot/batch number has been requested.
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| 51 | 2021-04-06 | swelling |
Approximately 2.5 hours after vaccination, I experienced difficulty breathing, overheating, and a se...
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Approximately 2.5 hours after vaccination, I experienced difficulty breathing, overheating, and a sensation of my head, neck, and chest swelling up. Emergency inhaler was used. Ice packs were applied to head and chest areas for 45 min. Breathing eased up slightly after about an hour. Tightness in chest and neck for next 4 hrs. Continued bouts tightness in chest and neck with labored breathing, lightheadedness, and vertigo over next 8 days. Took Zyrtec 2 times daily, inhaler 3 times daily, and Flexeril 2 times daily. Went to Urgent Care on day 8 after calls to allergy dr and gp dr were not returned. Prescribed Prednisone to help with inflammation.
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| 51 | 2021-04-10 | c-reactive protein increased |
Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of p...
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Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of pericarditis. Patient had previously had COVID-19 in 8/2020. Treated with prednisone and colchicine, pain improving on time of discharge.
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| 51 | 2021-04-20 | peripheral swelling, lymph node swelling |
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa...
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All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
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| 51 | 2021-05-04 | lymph node swelling |
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa...
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Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
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| 51 | 2021-05-10 | swelling | Site: Pain at Injection Site-Medium, Systemic: swelling near the neck-Mild |
| 51 | 2021-05-13 | swelling face, swelling |
About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started t...
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About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started to feel like getting swollen. Left half of my face started feeling swollen and tingling - like when your dental anesthesia was wearing off, and my left arm feeling swollen. I checked my left hand and my face on the mirror to see if they were really swollen, but they looked normal. I think it was more of the neurological effect. I can't remember if my left leg was also impacted. I think about 30 minutes or so, it started get better so I didn't go to see a doctor. About an hour after the shot, I think it was pretty much gone. Now, I may be too self conscious, but I feel like something wrong /weird with the left side of my body/face, but that may be my anxiety tricking me.
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| 51 | 2021-05-18 | swelling, swelling face |
Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in sof...
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Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in soft palate and uvula/Soft palate tingling then swelling including uvula (area tender from swelling); Having flare up with my rosacea/Redness on rosacea area; Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); Swelling in my face and throat; Tingling; Swelling in my face and throat; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old female patient non-pregnant received 1st dose of BNT162B2, (Pfizer covid-19 vaccine Formulation: Solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in arm left on 13Mar2021 09:45 as 1st dose, single for covid-19 immunisation. Medical history included allergy, insulin resistance, food intolerance, yeast, rice, spaghetti squash, hybrid pumpkin, yogurt, asthma, Thyroid and Hypermobility in joints. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) for Allergy; levothyroxine for thyroid; vilazodone hydrochloride (VIIBRYD); phentermine hydrochloride, topiramate (QSYMIA) and allergy Shot. No other vaccine was received in four weeks. Known allergies are Amoxcillin, Bactrim DS, yeast, rice, spaghetti squash, hybrid pumpkin, Betadine alcoolico, Metrogel, yogurt. Other medical history includes Allergies, asthma in remission, adverse reactions to Welbutrin, Contrave, Oxcarzepazine, Victoza. Patient had surgeries. Patient had blood drawn to check calcium level but don't know if that was within the last 2 weeks. On 13Mar2021 patient stated that I had my first Covid vaccination yesterday (13Mar2021) and I did report "Online" (further not clarified, hence captured as initial report) because I did have some swelling in my face and throat and there was sometimes that I was feeling a little dizzy here and there, so what I am worried about is, if I am going to not have the next vaccination because I am scared of the disease too. That's why I called. When paraphrased the concern, consumer stated, Yes and now the swelling that I had was on my soft palate and my uvula. It started tingling and then I did have some swelling there and on my face, I have rosacea and, so was having the flare up with my rosacea anyway, and that made all the areas that I had the redness of rosacea really pop-up red and then my lips were just slightly swollen and it was a little swollen around my nose and around my eyes and the dizziness it was just here and there, it was not anything big but this is a kind of reaction that I have, the thing the soft palate of my throat I have had that before when I had eaten eat something yeast and something like that, so I do not know is the shot may be have yeast so but I have not had that kind of slight swelling there on my face before, that's what I called. When probed for other Medical condition, consumer stated, I actually have allergies, they were pretty bizarre (not clarified) and Allergist calls me his special patient and I have food intolerances, so that's, the things right they are a lot of them. The thing that has calls me the most trouble is yeast. It does not matter if it is baker's yeast or brewer's yeast or yeast extract and I have unusual one like spaghetti squash and hybrid pumpkin, the spaghetti squash was the pumpkin and having that spaghetti squash in the hybrid pumpkin mainly react to it. In response to other medical condition, consumer stated, "There are other medication, I do have some other health conditions, I have Hypermobility in my joints, and I have a lot of "weird" (not clarified) things that I had like surgeries for different thing too but the main, and I am considered insulin resistance and I have had reactive low blood sugar at a time. Shot at 09:45 on 13Mar2021, experienced Soft palate tingling then swelling including uvula (area tender from swelling), mild swelling around nose, eyes and lips (areas feel tight sort of burn), intermittent mild dizziness. Redness on rosacea area. Benadryl -1 at 10:30, 1 at 11am, 2 at 2:41pm experienced headache (pain, pressure) at 01:45, Advil -1 at 07:45 experienced face flushed/hot feeling. Benadryl was self-administered as treatment. No covid prior vaccination and the patient was not tested for covid tested post vaccination. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
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| 51 | 2021-05-19 | lymph node swelling |
swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; swea...
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swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
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| 52 | 2021-01-02 | swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-03 | peripheral swelling | Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face) |
| 52 | 2021-01-03 | swelling face |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
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| 52 | 2021-01-04 | peripheral swelling | Nausea, lightheadedness, headache, fatigue, sore/swollen arm |
| 52 | 2021-01-05 | swelling face |
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ...
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Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
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| 52 | 2021-01-07 | lymph node pain, lymph node swelling | Fever, chills, nausea, lymph node enlargement with pain |
| 52 | 2021-01-07 | swelling |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-08 | lymph node swelling | Myalgia Left cervical lymphadenopathy, muscles feel weak. Narrative: |
| 52 | 2021-01-10 | swelling face |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-11 | lymph node swelling |
swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla,...
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swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla, starting approximately starting 45 hours post injection and continuing at time of this report
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| 52 | 2021-01-12 | swelling face | left side of face got swollen, 5 lb weight gain on 1/8/21, resolved on 1/12/21 |
| 52 | 2021-01-13 | anaphylactic reaction | Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium |
| 52 | 2021-01-13 | lymph node swelling | apple size lymph node arm pit of immunized arm after 2nd dose |
| 52 | 2021-01-13 | swelling face |
I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department a...
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I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department and developed severe facial swelling, primarily around the right eye. The left eye has slight swelling. Please note: I had a previous reaction to Tetanus many years ago that included swelling. In addition, I have had headaches and gastrointestinal symptoms.
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| 52 | 2021-01-13 | swelling face |
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on ...
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PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side. Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline. Is this possible Bells Palsy ?
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| 52 | 2021-01-14 | lymph node pain |
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f...
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Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
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| 52 | 2021-01-14 | white blood cell count increased |
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began ...
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I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
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| 52 | 2021-01-16 | lymph node swelling | headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness |
| 52 | 2021-01-16 | swelling face |
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. Th...
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I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen. No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken. Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
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| 52 | 2021-01-17 | axillary mass | Painful hard lump in left airpit |
| 52 | 2021-01-17 | peripheral swelling |
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben...
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Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
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| 52 | 2021-01-18 | lymph node swelling | Headache, fatigue, swollen left axillary lymph node |
| 52 | 2021-01-19 | peripheral swelling |
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE...
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RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
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| 52 | 2021-01-19 | swelling face |
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ...
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Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
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| 52 | 2021-01-20 | swelling |
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left...
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Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
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| 52 | 2021-01-21 | swollen extremities |
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI...
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GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
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| 52 | 2021-01-22 | lymph node swelling |
Dizziness, enlarged lymph nodes from axilla to mandible on same side as shot. Body aches, chills, h...
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Dizziness, enlarged lymph nodes from axilla to mandible on same side as shot. Body aches, chills, headache.
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| 52 | 2021-01-24 | lymph node swelling | Fever of 99-99.5 body aches. Nausea. Lack of appetite. Next day swollen lymph nodes only left side. |
| 52 | 2021-01-24 | lymph node swelling | Neck pain b/l sides radiating upwards to the jaw, swollen PAINFUL cervical lymph nodes, Fatigue, |
| 52 | 2021-01-24 | peripheral swelling |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | swelling face |
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ...
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My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
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| 52 | 2021-01-25 | lymph node swelling |
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati...
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Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
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| 52 | 2021-01-25 | lymph node swelling |
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and war...
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On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
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| 52 | 2021-01-26 | peripheral swelling | Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing |
| 52 | 2021-01-26 | swelling face | Face swelling and numbness, lightheaded, hot flashes with cold clammy skin |
| 52 | 2021-01-27 | lymph node swelling |
Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (p...
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Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-27 | lymph node swelling |
Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nod...
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Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left arm on 13Jan2021 at 16:00 at single dose for COVID-19 immunization. The patient medical history included hypertension and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BIAXIN and experienced allergy on an unspecified date, the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at left arm on 23Dec2020 at 15:45 at single dose for COVID-19 immunization. On 14Jan2021 at 03:00, the patient experienced injection site tenderness, fatigue, headache, fever, chills, muscle pain, axillary swollen lymph nodes. The patient outcome of the events was recovered.
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| 52 | 2021-01-27 | lymph node swelling |
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid...
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slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 52 | 2021-01-27 | swelling | I just noticed my right neck is a little swelled. My neck looks thicker than usual. |
| 52 | 2021-01-28 | swelling face |
Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on...
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Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on January 21. Generalized body itching started on January 26 and then woke up on January 27 with facial swelling. Instructed to follow-up with PCP or urgent care.
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| 52 | 2021-01-28 | swelling face |
Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritatio...
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Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritation from mask wearing. Then I had a burning sensation in my hair. Similar to a sunburn then getting chills. Wednesday night I noticed three pimple like bumps in my hair--right posteriorly. A bit itchy at times. Thursday right under my jaw line seems to have swelling. This morning it feels the same. Burning like irritation in my hair.
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| 52 | 2021-01-31 | anaphylactic reaction |
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest...
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Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
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| 52 | 2021-01-31 | lymph node swelling |
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil...
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Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
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| 52 | 2021-02-01 | swelling | Chills, Fever, Myalgia, Rash, Hives, Lymphedema, and Swelling |
| 52 | 2021-02-03 | anaphylactic reaction |
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ...
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Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
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| 52 | 2021-02-03 | swelling face, swelling, lymph node swelling |
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ...
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Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
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| 52 | 2021-02-03 | swelling |
2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swolle...
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2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swollen golf ball size knot. Tired but couldn't sleep. For 2 days severe hip bone pain, couldn't walk. day 2 H/A. Had constant severe urination. SOB, Low back pain. Entire skeletal system felt like she was in a car accident. Took 800mg ibuprofen. Had no energy 48 hours. 3rd day started to recover. Could not eat meals for 2 days.
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| 52 | 2021-02-06 | swelling face | My eyes and face swelled up and my left eye has been red, itchy, and sore since then. |
| 52 | 2021-02-07 | axillary mass |
Thrombosis in right axilla at superficial tributary. No Pulmonary embolism. Axilla pain developed wi...
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Thrombosis in right axilla at superficial tributary. No Pulmonary embolism. Axilla pain developed within 48 hours of vaccine. 1 week later she noted a lump at axilla. Presented to clinic for evaluation on 2/8/21
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| 52 | 2021-02-07 | peripheral swelling |
lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of ar...
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lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of arm, fatigue, hangover feeling
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| 52 | 2021-02-10 | lymph node swelling |
Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (...
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Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at 10:30 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Jan2021 at 10:00, the patient experienced swollen lymph nodes, which was considered non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
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| 52 | 2021-02-14 | peripheral swelling |
starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the t...
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starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the time she went to bed, she was experiencing extreme bloating and gas, and developed diarrhea soon after. on saturday 2/13, the patient's arm began to swell and a rash developed on several parts of the body (trunk, arms, legs). swelling and hives went away after patient took benadryl, diarhhea and bloating have lessened, by are still present as of monday 2/15
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| 52 | 2021-02-16 | lymph node pain, lymph node swelling | Tired Vaccine site tender Lymph node in arm pit slightly swollen and tender |
| 52 | 2021-02-17 | lymph node pain, lymph node swelling |
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i...
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chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
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| 52 | 2021-02-17 | lymph node swelling |
Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable...
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Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-02-19 | lymph node swelling | Left Supraclavicular Lymphadenitis the day after receiving the vaccine in Left Deltoid |
| 52 | 2021-02-20 | swelling |
Mod to severe local reaction and redness, swelling. Fevers 101.4, nausea, HA, chills, body aches, fa...
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Mod to severe local reaction and redness, swelling. Fevers 101.4, nausea, HA, chills, body aches, fatigue lasting 24 hours.
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| 52 | 2021-02-21 | lymph node swelling | Itching, swelling at injection site, pain, heart palpitations, lymph node swelling |
| 52 | 2021-02-21 | swelling face |
States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms reso...
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States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms resolved by next morning
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| 52 | 2021-02-21 | swelling |
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t...
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ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
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| 52 | 2021-02-22 | axillary mass |
exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of s...
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exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of small apple) in my left armpit. All symptoms subsided by Wednesday except exhaustion and lump.
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| 52 | 2021-02-22 | lymph node pain, lymph node swelling |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-23 | lymph node swelling |
Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in ...
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Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in bones and joints. Fever. Pain and swelling in the armpit of the arm where I was vaccinated.
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| 52 | 2021-02-23 | lymph node swelling |
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal...
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Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 52 | 2021-02-24 | lymph node swelling |
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left ar...
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I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm). I read online that this is a sign of my body fighting the vaccine and it is a good sign. I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye. My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not. She said that I needed to report my mass as it is not one of the most common side effects. I also went to the health department, where I had both shots, and had them look at the mass. They said the same thing about my body fighting the vaccine. My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine. Both of them said I needed to report this.
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| 52 | 2021-02-25 | swelling face | Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild |
| 52 | 2021-02-25 | swelling, peripheral swelling |
Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decrea...
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Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decreased in 48 hours, persists in shot arm, axillary and arm
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| 52 | 2021-02-28 | anaphylactic reaction |
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm...
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Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
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| 52 | 2021-02-28 | peripheral swelling |
Pain and swelling in left armpit. I've been applying warm compresses to area off and on for a couple...
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Pain and swelling in left armpit. I've been applying warm compresses to area off and on for a couple of hours per day at home.
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| 52 | 2021-02-28 | swelling face |
Swelling in the face; This is a spontaneous report from a non-contactable other health professional....
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Swelling in the face; This is a spontaneous report from a non-contactable other health professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 27Jan2021 (at the age of 52years) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in the face on 28Jan2021. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. This case is non-serious. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-03-03 | swelling |
Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccinatio...
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Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccination. Per pt report she had premedicated with Benadryl 100mg po prior to immunization and brought along her prescribed epi-pen. After reciept of vaccination, she proceed to recovery area where she was dictated to 30 minutes of observation, approximately 7 minutes after inoculation began having symptoms consistent with upper airway swelling and self-administered epi-pen and called for medical assistance. EMS was then called and upon arrival found her in stable condition and transported the patient to emergency room at Hospital.
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| 52 | 2021-03-07 | lymph node swelling, lymph node pain |
Lymph node in right armpit was swollen and very tender for 4 days. Swelling subsided by 4th day. T...
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Lymph node in right armpit was swollen and very tender for 4 days. Swelling subsided by 4th day. Tenderness subsided by third day. 1st and 2nd day large and very painful.
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| 52 | 2021-03-07 | lymph node swelling |
1/2 hour after receiving the vaccine she felt like her she felt like her throat was swelling and scr...
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1/2 hour after receiving the vaccine she felt like her she felt like her throat was swelling and scratchy. She said it scared her , and she ended up stopping at a store and took Benadryl and then she was ok. She?s doing better today but her Lymph nodes are swollen under her arm.
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| 52 | 2021-03-07 | peripheral swelling |
Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foo...
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Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foot
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| 52 | 2021-03-09 | lymph node swelling, lymph node pain |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x 2 days Headache x 2 days Muscle pain x 2 days Chills x 2 days Joint Pain x 2 days Fever up to 104.0 degrees x 2 days Nausea x 2 days Feeling Unwell x 2 days Swollen Lymph node left collarbone x 4 days
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| 52 | 2021-03-09 | swelling | R hand pain, redness, swelling, weakness, tingling |
| 52 | 2021-03-10 | lymph node swelling |
Swollen left axilla noticed 2 days after 2nd covid vaccine2/4/21. (same side as the vaccine was giv...
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Swollen left axilla noticed 2 days after 2nd covid vaccine2/4/21. (same side as the vaccine was given) I had a mammogram done 2/16/21 and was told I had abnormal results in my left lymph nodes in axilla. I had a left axilla ultrasound done 3/9/21 and the lymph nodes are still abnormal. I have been asked to come back in 8 weeks for another ultrasound.
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| 52 | 2021-03-11 | lymph node swelling, swelling |
pt states that she started itching between the left shoulder and left breast. As she scratched her ...
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pt states that she started itching between the left shoulder and left breast. As she scratched her breast she felt a small bump and noticed a brown spot. She contacted her OB/GYN via portal to let her know that about these symptoms. The Doctor advised her to see a Dermatologist. She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist. Pt saw Dermatologist on 3/4/2021 and was told it did not look skin cancer and ordered some cream. Pt let Dr. know that she had taken the vax recently and that she also has breast implants. The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN. Pt went to an already scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021. Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now. The pain seems to move around from breast to her back.
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| 52 | 2021-03-11 | swelling face |
Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. ...
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Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. Patient received Epinephrine 0.3 ml of 1 mg/ml solution IM, plus benadryl 50 mg p.o. Patient was transported to ED.
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| 52 | 2021-03-12 | peripheral swelling |
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f...
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15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
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| 52 | 2021-03-13 | lymph node swelling | Started experiencing nausea and swollen lymph nodes on Saturday, March 13. |
| 52 | 2021-03-13 | peripheral swelling |
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below kne...
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Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
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| 52 | 2021-03-13 | swelling face |
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ...
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Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
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| 52 | 2021-03-15 | lymph node swelling | Body aches, fatigue, lymphadenopathy left neck/axilla. |
| 52 | 2021-03-15 | peripheral swelling |
Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That...
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Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That lasted for 6 hours and transitioned to burning up. During this time I had severe pain in all joints from my neck to my hips. My fingers swelled as well. My legs felt fine and no headache. Tylenol and ibuprofen helped my fever but did not alleviate my pain symptoms. My shot was Friday evening. By sunday afternoon my fever was gone as well as the pain in all but my arm. But is was down to manageable.
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| 52 | 2021-03-18 | lymph node swelling |
Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoo...
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Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoon a large (ping pong ball sized) lump developed in the left axillary area that is very painful. The pain is constant when area is touched or with any arm movement. It feels like a knife is stuck inside my left axilla. I am guessing it may be a lymph node that swelled, but have not had it checked by a doctor. My last mammogram on November 16th, 2020 was clear and no indication of any lumps or swollen lymph nodes. This new lump appeared the following day after my Covid 19 vaccine.
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| 52 | 2021-03-18 | lymph node swelling |
Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneou...
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Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-03-18 | lymph node swelling |
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; l...
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Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.
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| 52 | 2021-03-18 | swelling face |
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue...
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Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
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| 52 | 2021-03-20 | lymph node swelling |
Swollen lymph node under left armpit (not in the arm pit) kind of near side of breast. About 3 inch...
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Swollen lymph node under left armpit (not in the arm pit) kind of near side of breast. About 3 inches around. It showed up yesterday around 3 or 4 pm -and I have taken naproxen. Too soon for outcome.
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| 52 | 2021-03-21 | axillary mass | Grapefruit sized lump in left axilla |
| 52 | 2021-03-21 | oral herpes | I have broken out with fever blisters on my lips. |
| 52 | 2021-03-21 | peripheral swelling |
warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vesse...
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warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vessels on 2 toes on one foot, and one toe on the other foot, started on 16 or 17th, March, still visible on March 22 - used some home made remedies and some triamcinolone, acetonide cream 0.1 % for the inflammation
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| 52 | 2021-03-22 | lymph node swelling, peripheral swelling | Pain in under arm and what appears to be a knot. Assuming it is a swollen lymph gland. |
| 52 | 2021-03-22 | peripheral swelling |
Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. S...
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Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. She said it started the day after receiving the vaccine.
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| 52 | 2021-03-23 | swelling |
Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not in...
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Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not involving lips.
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| 52 | 2021-03-23 | lymph node swelling, lymph node pain |
Light headedness; Swollen/ painful lymph nodes in armpit.; painful lymph nodes in armpit.; This is a...
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Light headedness; Swollen/ painful lymph nodes in armpit.; painful lymph nodes in armpit.; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 52-year-old, reported as currently 51-years-old, female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. Concomitant medications include paracetamol (TYLENOL) and synthetic elderberry [Sambucus nigra] syrup, both from unknown dates for unknown indications. The patient had not received any other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 29Jan2021 at 16:15 (at the age of 52-years-old) for COVID-19 immunisation. On 21Feb2021 at 08:30 the patient experienced swollen/painful lymph nodes in armpit and light headedness on the second day after the second dose. No treatment was provided for the events. The clinical outcomes of light headedness and swollen/painful lymph nodes in armpit were unknown. It was also reported that the patient had not been tested for COVID since vaccination.
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| 52 | 2021-03-23 | lymph node swelling, lymph node pain |
Arm at injection site and lymph node swelled to approximately 2 inches round the following morning w...
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Arm at injection site and lymph node swelled to approximately 2 inches round the following morning when I woke up. The arm is hot to the touch. Both places were extremely painful (especially the lymph node). The lymph node finally went down after 3 days. However, the lump at injection site is still large and now it's hard and it has the area has expanded to a "Covid Arm" rash, which covers my the majority of my upper arm. I was symptomatic with chills, aches for the first two days and the lump/lymph node issue is still happening and it's been 5 days.
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| 52 | 2021-03-23 | lymph node swelling, lymph node pain |
Eight days after the initial vaccine injection, a painful nodule appeared. I consumed a large amoun...
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Eight days after the initial vaccine injection, a painful nodule appeared. I consumed a large amount of (simple and complex sugar) calories (around 4,000) the night before 3/13/21. On the day of 3/13/21 I woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervical triangle. Saw my doctor on 3/18/21 and she mentioned that the inflamed lymph node is probably due to the vaccine. The lump is still with me, the size is the same, however the area in and around the lump is not as tender and painful today 3/24/21. This coming Friday 3/26/21 is my appointment for the second dose of the Pfizer BioNTECH vaccine shot.
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| 52 | 2021-03-23 | lymph node swelling |
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft...
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Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
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| 52 | 2021-03-23 | peripheral swelling |
her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to spli...
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her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
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| 52 | 2021-03-24 | anaphylactic reaction |
itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, neg...
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itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, negative dysphagia, negative airway or oropharynx component, admin 50 mg benadryl PO 12:45, admin famotidine 20 mg PO 1300, BP 130/80; HR 98; O2 sat 98% R.A., pharmacist monitored over time, pharmacist gave PO meds for home zyrtec and famotidine
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| 52 | 2021-03-24 | oral herpes | Fatigue, chills, and high fever in excess of 103 degrees. |
| 52 | 2021-03-24 | swelling face, swelling |
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt...
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I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
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| 52 | 2021-03-24 | swelling |
Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was m...
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Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was mild, but patient stated it has progressively gotten worse.
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| 52 | 2021-03-25 | anaphylactic reaction | Raised red rash on chest and anaphylactic symptoms |
| 52 | 2021-03-25 | lymph node swelling |
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l...
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Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
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| 52 | 2021-03-25 | peripheral swelling |
Day of injection started having pain in right armpit like a bruise. It has spread and very sore. It...
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Day of injection started having pain in right armpit like a bruise. It has spread and very sore. It is swollen also
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| 52 | 2021-03-26 | anaphylactic reaction | Shortness of breath, swelling of throat, atypical anaphylactic |
| 52 | 2021-03-27 | lymph node swelling |
Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still s...
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Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still slightly swollen but not painful as of today 03/28/21. Second dose is scheduled for 04/10/21.
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| 52 | 2021-03-27 | peripheral swelling |
Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine si...
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Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine site) and swelling and pustular rash and swelling with redness of L hand
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| 52 | 2021-03-28 | peripheral swelling |
medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to to...
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medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to touch. No itchiness
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| 52 | 2021-03-30 | lymph node swelling |
Severe fatigue, headache, fever. When those symptoms started going away, my left underarm lymph node...
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Severe fatigue, headache, fever. When those symptoms started going away, my left underarm lymph node swelled and became extremely painful. As of the time reporting this my underarm still hurts.
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| 52 | 2021-03-30 | swelling |
After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat ...
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After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat After 2hours find a red burning rash under breast/torax.Called health clinic, the Triage nurse directed me to hospital.Went to the Emergency room. Main Hospital Team Dr. Diagnose:allergic reatcion+Yeast infection. 7:28PM gave 3 pills prednisone. Pescription for Prednisone 20mg 3for4days, nyastatin podwder for rush, epinephrine injection in case of anaphylaxis, benadryl as needed.While I was at ER, the tingling/swelling expand my entire body left side. This night I had to remove wedding ring, today the face still swelling/warming+almost same/little bit worsening simptoms
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| 52 | 2021-03-31 | lymph node swelling |
swollen lymph node under left armpit the day after receiving the 2nd Phizer shot. It was a large si...
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swollen lymph node under left armpit the day after receiving the 2nd Phizer shot. It was a large size, about the size of a golf ball
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| 52 | 2021-03-31 | lymph node swelling |
About 2 weeks after the first dose, my lymph nodes on the left side of my neck and behind my earlobe...
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About 2 weeks after the first dose, my lymph nodes on the left side of my neck and behind my earlobe were very swollen and it was hard to turn my head. Also had a terrible headache. The swelling lasted 5 days and has gone down now. The headache lasted 2 days. I had a slight fever and body aches and tiredness for about 5 days after the vaccine.
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| 52 | 2021-03-31 | peripheral swelling, lymph node pain |
Swelling of most of L arm, hot to touch,red,painful,armpit lymph node pain, Headache Tired Light hea...
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Swelling of most of L arm, hot to touch,red,painful,armpit lymph node pain, Headache Tired Light headed Joint pain Temperature Red cheeks, hot to touch Stiff neck Congestion Coughing
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| 52 | 2021-03-31 | swelling |
Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of ...
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Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up muscle pain joint pain Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am Mar 31 Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering (reported side effects to Pfizer reporting mid day of Mar 30
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| 52 | 2021-03-31 | swelling |
Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burn...
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Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burning mouth syndrome for the past 3 years due to menopause it seems to be worse since the vaccine), tinnitus (also a preexisting condition but seems worse since vaccine)
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| 52 | 2021-04-02 | lymph node swelling |
She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling...
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She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received the second dose Pfizer BioNtech COVID 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EN6201), Injected in left arm unsure if given in muscle, on 09Feb2021 15:17 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First dose of Pfizer COVID 19 vaccine given on 19Jan2021, Lot EL3247, injected on left arm and unable to confirm if intramuscular. Patient reported that after COVID 19 vaccine second shot she had an allergic reaction and got it done late afternoon on Tuesday. The lymph node under he left arm pit is completely swollen and has been since yesterday early Wednesday (10Feb2021) morning around 04:30. The injection site also swelled up immediately (09Feb2021 15:17). She had all the other stuff too, but she is only concerned about these two. The outcome of the event swelling underneath her arm in the lymph node was not recovered, event Injection site swelling was recovering. and the outcome of the event hypersensitivity was recovered. No further details provided.
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| 52 | 2021-04-02 | peripheral swelling | Itching, redness, swelling of palms |
| 52 | 2021-04-03 | lymph node swelling |
I have a large lump on the lower portion of my neck on the same side as my shot was administered; Mo...
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I have a large lump on the lower portion of my neck on the same side as my shot was administered; Most likely lymph node very swollen.; This is a spontaneous report from a contactable 52-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 02Feb2021 at 08:30 am to 02Feb2021 at 08:30 am at single dose on left arm for covid-19 immunization. Patient was 52 years old and not pregnant at the time of vaccination. Patient's medical history included allergies to medications, food, or other products; Cipro and Keflex (dates unspecified). Historical vaccine included (other vaccine 4 weeks details, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; yes) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0142) via an unspecified route of administration from 12Jan2021 to 12Jan2021 at single dose on left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. Concomitant drugs (List of any other medications the patient received within 2 weeks of vaccination: No) were not reported. Patient reported that on 04Feb2021 at 04:00 pm ‘'I have a large lump on the lower portion of my neck on the same side as my shot was administered. It is about the size of two grapes. Most likely lymph node very swollen. Treatment received for the adverse event was reported as no. The reported events were considered as non-serious (serious; no, seriousness criteria-results in death; no, seriousness criteria-life threatening; no, seriousness criteria-caused/prolonged hospitalization; no, seriousness criteria -disabling /Incapacitating; no, seriousness criteria-congenital anomaly/birth defect; no). Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 was reported as no. The outcome of events was recovering.
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| 52 | 2021-04-03 | swelling |
noticed a painful lump, the size of a small grape above the left medial clavicle, within the supracl...
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noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle; noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle; woke up with swelling; This is a spontaneous report received from a contactable consumer. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6199), via an unspecified route of administration administered in left arm on 05Mar2021 14:30 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a hospital. No other vaccine in four weeks. Medical history included eczema and known allergies: gluten, dairy and soy sauce. The patient had no concomitant medications. The morning of 13Mar2021 at 05:00, the patient woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle. It was still with the patient and she was about to see her doctor today. No treatment was received for the events. The patient had no covid prior vaccination and was not covid tested post vaccination. The outcome of the events was not recovered.
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| 52 | 2021-04-04 | peripheral swelling |
Three hours after the injection of the 2nd dose, the right leg became swollen at a noticeable differ...
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Three hours after the injection of the 2nd dose, the right leg became swollen at a noticeable difference compared to the left leg. Extreme swelling around the ankle and the knee. Blood pressure at 136/83 and rate at 82 at 2pm. Doctor called and advised to go to the ER. Arrived at the ER and they reviewed vitals and discharged as they found a round red 1mm dot on the ankle and believed that a bug bit me shortly after the injection was given. It was possible a small gnat (no-see-ums) may have bit me as I did look down to scratch when I saw the swollen leg.
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| 52 | 2021-04-04 | swelling face, peripheral swelling | swelling in face and hands--cannot make a fist without pain |
| 52 | 2021-04-06 | swelling face, peripheral swelling |
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ...
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fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-04-08 | anaphylactic reaction |
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu...
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Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
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| 52 | 2021-04-13 | white blood cell count increased |
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COV...
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PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
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| 52 | 2021-04-14 | peripheral swelling |
04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I b...
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04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I began feeling so weak I could barely talk, I couldn't hold my eyes open. I took 3 Aleve. At 8pm, I started with shortness of breath just going downstairs plus my entire body felt like I was hit by a truck. My 3lb. Chihuahua would get on me and it felt like I was hit by a bat with a ripple effect into the surrounding area. I took 2 Tylenol PMs. On 04/07, at 6am, I woke up to my limbs extremely swollen and throbbing, this included both feet and especially both wrists and hands. My hands were worse than my feet. My left wrist/hand also had tingling. I was so weak I could barely get out of bed or talk, this continued through to 5:30pm same day. I called an Urgent Clinic and told her all my symptoms, she said were all "normal" until I got to my wrists/hands and limbs. Urgent Care told me it would be best to be seen in ER and evaluated. I immediately went to ER . This approximate time was 6:30pm on 04/07/21.
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| 52 | 2021-04-20 | sepsis |
COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; head...
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COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event "GI bleed" was fatal, the event "chest pain" and "body aches" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed
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| 52 | 2021-04-24 | anaphylactic reaction |
allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patien...
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allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received second dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 05Apr2021 09:15 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included hypersensitivity. There were no concomitant medications. The patient experienced allergic reaction (anaphylactic) (anaphylactic reaction) on 05Apr2021 09:15 few seconds after the second dose had taken Claritin the night before both shots and Benadryl 30 min before and on 2nd shot. 3 h later the reaction repeated and I took 2 more Benadryl Therapeutic measures were taken as a result of allergic reaction (anaphylactic) (anaphylactic reaction). The patient had recovered from the events. No follow-up attempts are possible. No further information is expected. .; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2.
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| 52 | 2021-04-28 | anaphylactic reaction |
anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contact...
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anaphylaxis; acute respiratory failure; short of breath; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Apr2021 10:00 (at age 52 years old) (Lot Number: EW0151) as single dose for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included diabetes mellitus (DM), hyperlipidemia, hypothyroidism, morbid obesity, mild mitral regurgitation (MR), hypertension (HTN), and known allergies to latex, all from unspecified date date and unknown if ongoing. No covid prior to vaccination. Covid tested post vaccination on 14Apr2021 with negative result. Concomitant medications included carvedilol (CARVEDILOL 1A PHARMA); lisinopril; fenofibrate; sitagliptin (JANUVIA); insulin lispro (HUMALOG); levothyroxine sodium (SYNTHROID); metformin; amlodipine besilate (NORVASC); vitamin d nos; magnesium; pravastatin; ASA; cinnamomum verum (CINNAMON); ferrous sulfate; all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 24Mar2021 (at age 52 years old) (lot no: ER8753 or ER 8733??) for COVID-19 immunization. No other vaccine in four weeks. The patient received second Pfizer COVID injection at 10 am. She waited 15 minutes then left facility. Within the next 5-10 minutes she became short of breath. She went to ER around 10:45 am and treated for anaphylaxis. She was put on the vent by 11 am or so for acute respiratory failure. She was negative for COVID, pulmonary emboli, and pneumonia. She had to be transferred to higher acuity hospital by critical care ambulance. She now is in ICU at a hospital on ventilator. The events occurred on 14Apr2021 at 10:30 AM. The events results in emergency room/department or urgent care, hospitalization. Treatment for events was reported as medical ER treatment then transferred to a hospital. The patient had not recovered from the events.
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| 52 | 2021-04-28 | peripheral swelling |
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen...
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blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 52 | 2021-05-06 | white blood cell count increased, lymph node pain, lymph node swelling, swelling |
24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was m...
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24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.
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| 52 | 2021-05-12 | anaphylactic reaction |
4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, ...
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4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, difficulty swallowing, dysphonia, hypertension, low saturation, hoarseness; 4:35pm Tx Epinephrine 0.3 mg IM, ECG, Benadryl 75 mg IV, 5:05pm transport to hospital, ECG, 5:15pm ECG, 5:35 pm famotidine IV, methylprednisolone sodium succinate IV Have had chronic dysphonia since.
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| 52 | 2021-05-14 | peripheral swelling |
throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swoll...
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throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.
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| 53 | 2021-01-02 | lymph node swelling |
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nur...
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I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
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| 53 | 2021-01-05 | c-reactive protein increased |
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms...
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In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
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| 53 | 2021-01-05 | peripheral swelling | States she had swelling in her forearm and hand |
| 53 | 2021-01-05 | swelling face |
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m...
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FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
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| 53 | 2021-01-06 | lymph node swelling |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-07 | lymph node pain, lymph node swelling |
swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node...
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swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node in left neck/clavicle area after about several days; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on 24Dec2020 08:00 (left arm) at single dose for covid-19 immunisation. Medical history included depression, hypertension (HTN), and high cholesterol. The patient had allergies with sulfa and beta blockers. The patient's concomitant medications were not reported. The patient previously took pravastatin sodium (PRAVACHOL) and experienced allergies. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2 vaccine and received other medications within 2 weeks of vaccination but were unspecified. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced swollen/sore lymph node in left neck/clavicle area after about several days on an unspecified date (reported as "01Dec2020", pending clarification). The reported events were non-serious. The patient did not receive treatment for these reported events. The outcome of the events was not recovered.
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| 53 | 2021-01-07 | lymph node swelling, peripheral swelling, lymph node pain |
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with di...
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1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling. Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest. Food aversion at breakfast - could not tolerate eating more than a few bites. Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening. Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving. Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck. Continuing to take ibuprofen with some food 3x per day
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| 53 | 2021-01-07 | peripheral swelling |
Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (...
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Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 53 | 2021-01-07 | peripheral swelling |
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I...
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My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
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| 53 | 2021-01-08 | lymph node swelling |
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes...
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1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
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| 53 | 2021-01-08 | swelling, lymph node swelling |
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling a...
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Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.
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| 53 | 2021-01-10 | lymph node swelling |
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever...
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1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
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| 53 | 2021-01-10 | lymph node swelling | lymphadenopathy under right arm. still on going today |
| 53 | 2021-01-10 | swelling face |
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, ...
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At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.
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| 53 | 2021-01-11 | lymph node pain |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | lymph node swelling |
Patient developed supraclavicular lymph node nodule 7 days post vaccination on left side of body. C...
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Patient developed supraclavicular lymph node nodule 7 days post vaccination on left side of body. CT scan and biopsy completed 8 days post vaccination. Biopsy was normal/non-cancerous.
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| 53 | 2021-01-11 | swelling | I have a red silver dollar sized hard lump that is red and warm |
| 53 | 2021-01-12 | anaphylactic reaction |
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co...
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anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-12 | swelling |
1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:...
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1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:30 PM ON 1/11/21 AND SYMPTOMS BEGAN WITH BEING AWAKENED BY FEELING ITCHINESS ON STOMACH AT APPROX 01:30 A.M. ON 1/13/21. PATIENT (I) OBSERVED BUMPINESS AND REDNESS COVERING ENTIRE STOMACH, BACK OF NECK AND ITCHINESS DOWN THIGHS AND ALONG UNDER SIDE OF ARM. TOOK BENADRYL OTC AND WENT BACK TO BED. AWOKE FOR WORK AT 04:30 AND SYMPTOMS ARE BETTER. NO SHORTNESS OF BREATH OR OTHER ALLERGY RELATED SYMPTOMS
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| 53 | 2021-01-13 | lymph node pain, lymph node swelling |
Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest a...
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Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization. Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
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| 53 | 2021-01-13 | lymph node swelling |
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ...
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I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
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| 53 | 2021-01-13 | lymph node swelling |
Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17D...
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Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17Dec2020 and second dose on 04Jan2021 (18 days apart); This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 04Jan2021 at 10:00 (second dose) on the right arm, and on 17Dec2020 at 15:00 (first dose) on the left arm; both via unspecified routes of administration at a single dose for immunization. Medical history included hypertension and liver disease. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), ibuprofen, paracetamol (TYLENOL), propanol, and sennoside a+b (SENOKOT). The patient experienced lymphadenopathy and fatigue on 05Jan2021 at 05:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.
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| 53 | 2021-01-14 | swollen extremities, lymph node pain, lymph node swelling |
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ...
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Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
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| 53 | 2021-01-15 | lymph node swelling |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-17 | lymph node swelling, swollen extremities |
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain an...
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neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits. currently have increased paresthesia arms, hands, legs and feet
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| 53 | 2021-01-18 | lymph node swelling | left sided cervical adenopathy |
| 53 | 2021-01-18 | lymph node swelling |
Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness,...
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Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness, dizziness. Symptoms improved. Went to ER on 1/16/21, Covid test neg.
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| 53 | 2021-01-18 | lymph node swelling |
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injec...
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Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day. I took Tylenol which did help fever and body aches. I had symptoms until 1/11/21 and started feeling better at 11 am.
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| 53 | 2021-01-19 | lymph node swelling, swelling face |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | swelling face |
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The...
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Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
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| 53 | 2021-01-19 | swelling |
Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Fa...
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Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Famotidine taken. Admitted to ED at 4 am on January 18, Prednisone given. Symptoms were improving and discharged at 7 am the same day. Hives and itching were worse and facial edema and rash noted on night of January 18. Treatments included Benadryl and Famotidine. Morning of January 19, 40 mg Prednisone and Benadryl every 4-6 hours. Morning of January 20, hives and rash and itching persists on stomach, legs, arms, and ears. 40 mg of Prednisone and Benadryl. (Present time - hives, rash, and itching still persists with less severity)
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| 53 | 2021-01-21 | swollen extremities, lymph node swelling | edematous changes in L axillary region with inflammed lymph nodes |
| 53 | 2021-01-23 | lymph node swelling |
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During ...
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At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol. Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
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| 53 | 2021-01-25 | peripheral swelling |
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches....
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Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
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| 53 | 2021-01-25 | swelling |
patient swelled up really large. had to remove rings and clothing. also felt very badly with headach...
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patient swelled up really large. had to remove rings and clothing. also felt very badly with headache for the next few days.
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| 53 | 2021-01-26 | lymph node swelling |
Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left a...
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Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left arm. Whole body inflammatory response. Treatment: Ice, Tylenol and Hydrocodone. Called physicians office to inform. Awaiting call back if anything needs to be done.
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| 53 | 2021-01-26 | lymph node swelling |
Fever, headache, chills, dizziness, fatigue, body aches, swollen lymph nodes under arm, cervical ...
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Fever, headache, chills, dizziness, fatigue, body aches, swollen lymph nodes under arm, cervical nodes. Started at 2 AM. After vaccine lasted until 1/23/2021
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| 53 | 2021-01-27 | lymph node swelling | swollen painful 1cm lymph node under arm near left breast |
| 53 | 2021-01-27 | lymph node swelling |
Had significant painful axillary lymphadenopathy on the injection side; This is a spontaneous report...
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Had significant painful axillary lymphadenopathy on the injection side; This is a spontaneous report from a contactable Other HCP. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for COVID-19 immunization. None Medical history. No covid prior vaccination. The patient's concomitant medications were not reported. On 13Jan2021, patient had significant painful axillary lymphadenopathy on the injection side that resulted in doctor/other healthcare professional office visit. No treatment received. The event outcome was unknown. No covid tested post vaccination. Information on the lot/batch number has been requested.
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| 53 | 2021-01-28 | peripheral swelling |
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ...
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Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
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| 53 | 2021-01-31 | peripheral swelling |
swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as va...
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swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as vaccine received)
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| 53 | 2021-01-31 | swelling, lymph node swelling |
Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red ra...
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Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 53 | 2021-02-01 | swelling face | Facial swelling, itching, tightness, eyelid dropping |
| 53 | 2021-02-02 | swelling face |
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che...
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Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
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| 53 | 2021-02-03 | peripheral swelling |
first shot my arms and neck muscles went numb for several hours Second time my legs were in severe ...
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first shot my arms and neck muscles went numb for several hours Second time my legs were in severe pain and hard to make move-could barely walk. This lasted for about 8 hours. I had a small fever, my left leg and ankle swelled for several days and hurt mildly. I had a rash on my neck and body. I had fatigue like theonset of a fibro attack both times but second shot was much worst than first.
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| 53 | 2021-02-07 | swelling face |
SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 ...
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SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 AND BECAME WORSE LATER THAT MORNING. EXTREME TIREDNESS. TOOK BENADRYL TO RELIEVE THE ITCHING AND SWELLING.
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| 53 | 2021-02-09 | swelling |
Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling...
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Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 53 | 2021-02-10 | lymph node swelling, peripheral swelling |
left arm swollen, lymph nodes swelling headache, dizziness, generalized malaise form head to toe, ch...
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left arm swollen, lymph nodes swelling headache, dizziness, generalized malaise form head to toe, chills as well.
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| 53 | 2021-02-14 | lymph node swelling |
Nearly blacked out/passed out after I woke up on 2/14 Sluggish with chills and aches the rest of the...
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Nearly blacked out/passed out after I woke up on 2/14 Sluggish with chills and aches the rest of the day Noticed enlarged lymph node in the left arm pit region on 2/15
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| 53 | 2021-02-15 | lymph node swelling | nausea, headache, muscle aches, fatigue, swollen lymphnodes in armpit (left side) |
| 53 | 2021-02-15 | oral herpes, swelling face | Cold sore type of reaction under my nose which has now spread to the ball of my nose with swelling |
| 53 | 2021-02-18 | swelling |
Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-...
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Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-19 Pfizer Vaccine. Post vaccination patient noted left arm pain to elbow and left supraclavicular swelling moving laterally. Noted tingling and pain then swelling in left neck/shoulder area. About size of a baseball. Patient given option to take benadryl 25 mg once before leaving or take it later if she is not improving. She prefers to take it now. Benadryl 25 mg PO x1 given at 1715 self-administered. Patient monitored for a total 40 minutes before being released. History of reaction to flu vaccination that resulted in arm swelling and high fever ~30 years ago. Vancomycin life threatening reaction.
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| 53 | 2021-02-19 | lymph node swelling, swollen extremities | Supra clavicle swelling slowly decreasing and mild auxiliary edema resolved |
| 53 | 2021-02-20 | lymph node swelling, lymph node pain |
Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm an...
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Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm and hand.
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| 53 | 2021-02-22 | anaphylactic reaction |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-22 | lymph node pain |
2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and fre...
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2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 – Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 – Woke feeling tired but better. 2/22/21 – In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 – woke up feeling better.
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| 53 | 2021-02-22 | peripheral swelling |
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot...
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1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
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| 53 | 2021-02-24 | lymph node pain, lymph node swelling |
slightly painful swollen lymph node on her left side near the clavicle and it was tender when touche...
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slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on the left arm, on 26Jan2021 13:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered at the workplace clinic. The patient experienced having a slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched on 27Jan2021 10:00. No treatment was received for the adverse events. The patient had not recovered from the adverse events at the time of the report. The patient has not been COVID tested post vaccination.
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| 53 | 2021-02-24 | swelling | Pfizer COVID-19 vaccination. |
| 53 | 2021-02-25 | lymph node swelling |
suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from a...
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suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
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| 53 | 2021-02-26 | lymph node swelling, lymph node pain | Lymph nodes swollen and sore |
| 53 | 2021-02-26 | lymph node swelling |
Severe fatigue, muscle pain, headaches, swollen cervical and axillary nodes for over 1 month. From ...
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Severe fatigue, muscle pain, headaches, swollen cervical and axillary nodes for over 1 month. From about 1/18/21 until now.Swelling in lymph nodes has subsided some in the last week and the fatigue has also subsided some. I saw my primary Dr, on 2/17/21 for a routine check up and he did note my lymph nodes were all swollen. I told him my symptoms and he stated I could be having an immune response to the COVID vaccine. I had none of the above symptoms before receiving the COVID vaccines.
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| 53 | 2021-02-28 | swelling |
Angioedema, team; recommended 60 minute evaluation . No further intervention Diagnosed with acute...
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Angioedema, team; recommended 60 minute evaluation . No further intervention Diagnosed with acute allergic reaction without anaphylaxis. 1120 135/85 24 RR 69 HR 100% O2 Sat. 1130 98% O2 Sat, 20 RR, 71 HR. 1140 98% 68 HR 20 RR. Discharged at 1140. Patient stable.
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| 53 | 2021-02-28 | lymph node swelling, oral herpes |
Large cold sore/lesion on top left lip - open - treated at home with abreva/hydrogen peroxide. Pain ...
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Large cold sore/lesion on top left lip - open - treated at home with abreva/hydrogen peroxide. Pain from top of lip to left eye, pain bottom lip, gland swollen under left side of mouth. Lips became very dry. Has not totally gone away, still treating at home no pain from lip to eye or mouth anymore gland not swollen. However intense pain lasted four days.
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| 53 | 2021-02-28 | swelling face, swelling |
Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness ...
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Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-02-28 | swelling face |
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in...
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Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-03-01 | lymph node pain |
tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-hea...
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tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-headache in occipital bone -2/26 went to hospital, paralyzed in left side of face, bells palsy
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| 53 | 2021-03-01 | lymph node swelling |
LYMPHADENOPATHY (LYMPH NODE SWELLING IN THE AREA BETWEEN THE NECKA ND THE COLLARBONE ON THE SIDE OF ...
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LYMPHADENOPATHY (LYMPH NODE SWELLING IN THE AREA BETWEEN THE NECKA ND THE COLLARBONE ON THE SIDE OF INJECTION
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| 53 | 2021-03-02 | swelling | Hives, bumps in the whole body, red and warm skin, itchy and swelling |
| 53 | 2021-03-03 | swelling |
Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve i...
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Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve in lower neck/ upper back where left arm connects. Numbness/weakness in left arm and pain upon lifting arms above shoulders. Either side but significantly worse on left side. Limited mobility to move neck and head without pain unless medicated. Muscle spasms left of spine in upper back/neck and tingling down left arm. Severe pinched nerve pain that got progressively worse from onset.
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| 53 | 2021-03-04 | lymph node swelling | I had a swollen lymph node on left arm lasting 5 days. |
| 53 | 2021-03-04 | lymph node swelling | Swelling in lymph nodes on left side of body. Armpit area. Painful. |
| 53 | 2021-03-08 | lymph node swelling | Extreme swollen lymph nodes in my armpit |
| 53 | 2021-03-08 | peripheral swelling |
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hou...
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Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
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| 53 | 2021-03-09 | lymph node swelling |
The next day, the lymph node on the left side on my underarm was swollen/enlarged. I felt feverish. ...
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The next day, the lymph node on the left side on my underarm was swollen/enlarged. I felt feverish. I went to the Dr and she ordered an ultrasound and an mammogram but I didn't get it because I heard on news that they advised to wait until the swelling had a chance to go down before getting an ultrasound and mammogram. The swelling went down after a week. It was so swollen I couldn't put my arm down. I will get my tests done for six weeks.
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| 53 | 2021-03-09 | swelling face |
Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. ...
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Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. Gave 0.3mg epipen vastus lateralis. Brought patient to ER via wheelchair
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| 53 | 2021-03-10 | swollen extremities |
injection pain, nausea, dizziness, headache immediately following injection pain, swelling in undera...
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injection pain, nausea, dizziness, headache immediately following injection pain, swelling in underarm 2 days following injection Continues to be problematic
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| 53 | 2021-03-10 | peripheral swelling |
pain and swelling in underarm area of same arm where received vaccination. This started approximatel...
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pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
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| 53 | 2021-03-14 | peripheral swelling |
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:...
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I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
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| 53 | 2021-03-15 | swelling |
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w...
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Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
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| 53 | 2021-03-17 | lymph node swelling |
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM...
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neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-03-17 | swelling, swelling face |
My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face a...
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My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face and neck itchy.
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| 53 | 2021-03-18 | lymph node swelling |
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute...
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received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
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| 53 | 2021-03-18 | swelling |
On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up...
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On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up next day after a great sleep and arm was just a little sore but I was totally exhausted and napped through the day and went to sleep that night. Wednesday the 17th of march I woke up at 4:30 in morning with a screaming headache and my neck and shoulder muscles were extremely tight. I felt like my head was going to explode! I am not used to headaches but this one hurt pretty bad. I took Tylenol and used ice packs on head and neck and back shoulders. I used Electronic Muscle Stimulator Pads for 12 minutes on middle shoulder back area. That evening I was feeling a little better with small headache but when i was rubbing
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| 53 | 2021-03-18 | swelling | Sore throat with coughing and swelling, fever chills muscle aches, headache |
| 53 | 2021-03-21 | lymph node swelling, swelling face |
swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (pati...
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swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18Feb2021 at 14:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was no diagnosed with COVID-19. Concomitant medications included cetirizine (ZYRTEC) from an unspecified date for an unspecified indication. The patient previously received naproxen from an unspecified date for an unspecified indication and experienced allergy. The patient also had allergies to beeswax, honey, chemical aerosol sprays, and perfumes. On 18Feb2021 at 16:45, approximately three hours after the vaccine, the patient experienced facial swelling and swollen lymph nodes. The events were reported as non-serious. The patient went to the emergency room/department of urgent care as a result of the event and received treatment with high dose diphenhydramine (BENADRYL). The outcome of facial swelling and swollen lymph nodes was recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 53 | 2021-03-21 | lymph node swelling, swelling |
Lump, redness, and heat in injection site on the day after the second shot. The second day after t...
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Lump, redness, and heat in injection site on the day after the second shot. The second day after the shot developed swelling in the neck on left side between neck and shoulder area. Third day lymph node swelling and pain when swallowing. Arm still red, swollen and hot on third day after the shot. I have iced down both area which has not helped. I contacted occupational health as I work at a hospital and received the vaccine there. I was told to contact my PCP, which I did and am waiting to hear back.
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| 53 | 2021-03-21 | lymph node swelling | FEVER, ACHES, SORE THROAT, SWOLLEN GLANDS, HEADACHE, STIFF NECK...SO FAR GOING ON TWO DAYS |
| 53 | 2021-03-21 | swelling face |
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ...
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Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
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| 53 | 2021-03-22 | peripheral swelling |
Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to h...
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Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to hospital. They found a blood clot in my leg .
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| 53 | 2021-03-23 | lymph node swelling | lymph node under arm left arm swollen, left side gums imflamed and left eye eyelid imflamed. |
| 53 | 2021-03-24 | swelling |
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ...
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Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
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| 53 | 2021-03-25 | lymph node swelling | Body aches, fatigue, nausea, headache, lymph node above collarbone swollen. |
| 53 | 2021-03-25 | peripheral swelling |
Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When ...
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Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When her vitals were taken everything was normal. She asked to be transported to have further observation.
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| 53 | 2021-03-26 | lymph node pain, lymph node swelling |
Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I...
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Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I consider this minor compared to contracting COVID-19
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| 53 | 2021-03-26 | lymph node swelling, axillary mass |
Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left ar...
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Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left arm at vaccine location.
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| 53 | 2021-03-28 | lymph node swelling | Hives to chest and arms, Swollen left neck lymph node, diarrhea, injection site warm |
| 53 | 2021-03-28 | swelling face |
One week after 1st vaccine, woke up with 3 blisters on inside of upper lip. No other side affects. ...
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One week after 1st vaccine, woke up with 3 blisters on inside of upper lip. No other side affects. After 2nd shot, I did have a slight headache, but not any different than the headache I get with seasonal allergies. No medicines required. Then 51 hours after the 2nd shot, I started having swelling on left side of the face (cheek area). Took Benadryl and iced it, swelling subsided slightly. Approximately 6 hours later, swelling return and is not more swollen than before. Taking additional Benadryl and Zyrtec and following up with an ENT doctor in AM if symptoms do no subside.
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| 53 | 2021-03-30 | lymph node swelling |
swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This ...
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swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El3249, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 27Jan2021(at the age of 53 years) as single dose for COVID-19 immunization. Medical history included hypothyroidism , migraine and rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid taken for an unspecified indication, start and stop date were not reported. The patient also took BCP in two weeks. The patient previously took cipro and experienced drug hypersensitivity, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231, expiration date: not reported) via intramuscular route of administration, administered in Arm Left at 09:15 on 06Jan2021 as single dose for COVID-19 immunization and experienced malaise. The patient experienced swelling to left underarm lymph node, pain at site and left arm "ache" with decrease in strength on 28Jan2021. The outcome of events was recovering.
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| 53 | 2021-03-30 | swelling face | Pfizer-BioNTech Covid-19 Vaccine Swelling of face, lips and throat / Numbness |
| 53 | 2021-03-31 | lymph node swelling |
Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and f...
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Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and fatigue still lasting one week later. Swollen lymph nodes in neck and mild sore throat noticed approximately 5 days after and still lasting one week after shot.
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| 53 | 2021-04-01 | lymph node swelling, lymph node pain |
Site soreness, headache, within 5 hours, Fever (100.7), muscle pain, aches, chills, sweating at 16 ...
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Site soreness, headache, within 5 hours, Fever (100.7), muscle pain, aches, chills, sweating at 16 hours after vaccine and lasting through the next 24-36 hours. After this time large, swollen, very tender lymph nodes u under left armpit (same as injection) and slight tenderness under right armpit. This lasted another 2 days. Muscle pain in my lower back was the most intolerable of the symptoms as this continued well after my fever broke.
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| 53 | 2021-04-01 | lymph node swelling |
extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts t...
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extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts to turn or tilt head - sore to touch and affecting swallowing and voice - raspiness and cracking - dryness of throat
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| 53 | 2021-04-01 | peripheral swelling | My left are is still swollen and is a little tender to touch. There is a big lump on my upper arm. |
| 53 | 2021-04-01 | swelling face |
Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the fe...
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Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the feeling of passing out, super hot throughout my body. Numbness in left cheek and upper lip. Swelling in left cheek and left eye. Dizzy.
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| 53 | 2021-04-02 | lymph node swelling | Whole arm aches today. Injection site warm to touch and armpit lymph node very swollen |
| 53 | 2021-04-02 | peripheral swelling |
Itching on the right fifth finger, and slightly swollen. SBP 154 (pulse 95), 96% O2 sat. Final BP 15...
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Itching on the right fifth finger, and slightly swollen. SBP 154 (pulse 95), 96% O2 sat. Final BP 152/93 (pulse 91), O2 sat 97%.
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| 53 | 2021-04-02 | swelling face | PUFFY/SWOLLEN AND IRRITATED EYES; SWOLLEN FACE; SNEEZING, CONGESTION, DIZZY, LETHARGY TINITUS. |
| 53 | 2021-04-03 | lymph node swelling |
Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General ache...
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Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General aches and injection site soreness. All symptoms are on the left side, the same side of the injection site. Started around 4 pm on Friday 4/2/2021. I took 500mg of Tylenol on Friday at 8pm, and at 2am on Saturday 2/3/2021.
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| 53 | 2021-04-06 | anaphylactic reaction |
This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-p...
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This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 53 | 2021-04-13 | swelling face |
Face swelling within an hour of vaccination. Following day: itching, rash and sore throat (described...
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Face swelling within an hour of vaccination. Following day: itching, rash and sore throat (described as raw), cough Pt self-treated with diphenhydramine
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| 53 | 2021-04-24 | anaphylactic reaction |
anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. Th...
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anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 53 | 2021-04-24 | lymph node pain |
she began to feel like she was straining to take a deep breath. When she would take a deep breath (l...
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she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events. The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events. Follow-up attempts are completed. No further information is expected.
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| 53 | 2021-04-24 | swelling |
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout...
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Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
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| 53 | 2021-04-26 | anaphylactic reaction |
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her...
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This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
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| 53 | 2021-05-02 | anaphylactic reaction |
Within 5-10 minutes, I started to cough. My elbows started to itch, then my face/ears. After 30 minu...
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Within 5-10 minutes, I started to cough. My elbows started to itch, then my face/ears. After 30 minutes, I told the head nurse that I was going to drive home as it didn't seem to be progressing further than a bit of cough and some very minimal itching. By the time I got to my car, it was a bit worse and I opted to just try to get home for a cold shower and Benadryl. After 10 minutes of driving, I turned around and went back to hospital with a full blown anaphylactic reaction -- throat closing, gasping for breath, unable to talk due to coughing. Nurse walked me through the hospital to the ER where I was given epinephrine injection in Rt thigh & 25 my Benadryl in Rt arm about an hour after vaccination.
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| 53 | 2021-05-04 | peripheral swelling |
the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. ...
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the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. That area is prone to dry skin.; pretty tired; shortness of breath; chest pain; rash/rash around right arm; Redness in right arm at mastectomy site, and warm to touch; Welts; red bumps; Itching; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left deltoid on 19Apr2021 14:30 at single dose for COVID-19 immunisation. Medical history bipolar disorder, breast cancer, and slightly high blood pressure. Patient had a right mastectomy and had lymph nodes removed from the right side. In the spring, when everyone was mowing grass and it was real humid outside, she got welts on her body. It was temporary and went away. Patient would get really itchy. Concomitant medications included letrozole for breast cancer (the tumor in her breast was powered by hormones. This drug suppressed hormones) from 2017 and ongoing, omeprazole for constant heartburn from an unspecified date and ongoing, propranolol hydrochloride (PROPANOLOL) for anxiety from 2016 and ongoing, clonazepam for anxiety from 2016 and ongoing, and venlafaxine hydrochloride (EFFEXOR) for bipolar disorder from an unspecified start date and ongoing. Patient previously received the first dose of BNT162B2 in left deltoid on 29Mar2021 11:30 for COVID-19 immunisation and was really tired after the first vaccine. When she was a kid, her doctor put her on steroids. Never happened after age 12. Patient also got the influenza vaccine (flu shot) a couple of years before. The patient experienced redness in right arm at mastectomy site, and warm to touch, welts, red bumps, itching, and nauseated on 20Apr2021. Patient had a right mastectomy and had lymph nodes removed from the right side. In the area where that occurred, it had become red, inflamed, and a little welty. Not all of the welts were raised, they look like they were in the skin. There was redness and it was like someone scratched her and was kind of itchy. She took 2 diphenhydramine hydrochloride (BENADRYL). Patient was very sensitive to allergies, but was not allergic to anything. Sometimes she broke out in welts in the spring. Patient got the injection in the left side but the reaction was occurring in the right side. Patient was pretty tired, but she was concerned about the rash. Patient was concerned that the right arm was roughly 2" bigger than the left arm around it. Patient had been measuring the circumference, because nurses were paranoid about things like that. It was usually not 2" more around. Patient woke up this around 10:00 am. Around roughly 12:20 pm, or probably 10 after 12, she looked in the mirror and said there it was. She noticed the itching and thought it was dry skin. That area was prone to dry skin. The welty points of redness that were raised. It looked like someone had scratched across the area. It was red, and might be the end of one red scratchy area might be a bump. It looked like, if were to put hand where the nipple used to be and open up the area. That would all be covered. It included the upper arm and the inside of the shoulder, like the front side of the shoulder. It was raised and welty redness. Not all areas were raised and was bumpy. It was all pretty red and warm to the touch. The itchiness started more after she saw it, which was terrible. Patient took diphenhydramine hydrochloride because she was concerned about an allergic reaction. She also had scheduled medications that she took in the morning. Patient took 50 mg diphenhydramine hydrochloride this morning. Patient took at 12:10 pm when noticed these things. At first, she didn't think anything, she didn't think like it was the Pfizer shot or anything. It was just a normal day. Diphenhydramine hydrochloride had done nothing for the welts yet. Patient then felt kind of nauseated. It started when we first got on the phone. She couldn't put her finger on it. Patient went to the emergency room last Monday. The incident had nothing to do with any vaccine. She had chest pain and shortness of breath. They drew all of the labs. If she wanted to know if anything in the labs was different from then and now, she could. Everything was normal. She got an inhaler. They though it might be related to all of her allergies. The only way she would go see a doctor, is if she saw that the arm was getting much bigger, like it grew 2" more. If she had a hard time breathing, she would call 911. Patient had rash around right arm on 20Apr2021, in area of past breast mastectomy. Patient first noticed itching and the redness around 12:20 pm on 20Apr2021. Had gotten progressively worse. Patient did not see in the emergency department and was not hospitalized. Patient was not admitted to an Intensive Care Unit. Multiorgan were involved. Patient just noticed new area that formed. There were lines coming out of the area and came below the sleeve line. The red rash was spreading. It looked like something invisible scratched it. There was a triangle of three dots with a little scratch mark below the sleeve. There was another dot area on the forearm that itches, just like the other stuff did. Stomach had been feeling a little jumpy. Patient had already eaten breakfast. It was not horrible. Patient would watch it and drink ginger ale. Patient was asking what parameters should be for calling 911. She was home alone. This was not life threatening but if it turned into something bigger or if she noticed getting a bigger rash, she might have to call 911. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 53 | 2021-05-10 | lymph node swelling, lymph node pain |
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremo...
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swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 53 | 2021-05-11 | swelling face |
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of...
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: PATIENT COMPLAINT ABOUT SWELLING AND REDNESS ON EYE AND FACE; PATIENT WAS CONTACTED 4HRS LATER AND WAS BETTER AFTER TAKING BENADRYL. SHE DECIDES TO SEE HER PCP AFTER
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| 53 | 2021-05-12 | white blood cell count increased, c-reactive protein increased |
shortly after vaccine, experience chest tightness, palpitations, dyspnea, cough, sweating and fever....
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shortly after vaccine, experience chest tightness, palpitations, dyspnea, cough, sweating and fever. Admitted to hospital 3 days later, found to have new pericardial effusion, secondary to acute pericarditis from possible vaccine. Pericardiocentesis removed 250ml proteinaceous material. Also experienced flash pulmonary edema which required intubation x1 day but resolved quickly.
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| 53 | 2021-05-14 | anaphylactic reaction |
anaphylaxis; This is a spontaneous report received a contactable consumer (patient) from a 53-years-...
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anaphylaxis; This is a spontaneous report received a contactable consumer (patient) from a 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EP6955, expiry date not reported) via an unspecified route of administration on 30Mar2021 as first dose, single for covid-19 immunisation. Medical history included asthma and autoimmune disorder, both from an unknown date and unknown if ongoing. Patient received her 1st dose on 30Mar2021 but experienced a bad reaction (anaphylaxis) on an unspecified date in 2021. She was afraid to take her 2nd dose since its risky. She was asking if she can take an alternative vaccine for her 2nd dose (Moderna) or she needs to stop. She needed to know how to move forward for dose 2. She needed hospitalizing and it was to the point she needed to call 911 but it resolved and materialized at home. She clarified that instead of going to the hospital it was a close call at home. She said she used her rescue inhaler because she was an asthma person. She used her rescue inhaler over the course of a few days and it resulted in settling the issue. It lasted several days. She needed to also submit a safety report over to VAERS. She wanted to submit over there as well, online or call in. Her question was she had a really bad case and nearly had to go to the ER and thought she would die with dose 1, she waned to know if she should get dose 2. She looked it up through the CDC and it says do not continue dose if she had anaphylaxis. She reached out because she does not feel comfortable about the adverse effects. If she experienced adverse effects, she asks if she can get a different vaccine. The CDC website says she may chose to take different vaccine. She wants to know if she can take another vaccine. She wants to know what's in the Pfizer vaccine, asking what are in the ingredients. Right now, she has one vaccine in the system. She wanted to know how effective is it to prevent her from catching covid. How much protection does she have from one dose. The lady just read the statement to her that people who are immunocompromised she was told something that it would have a lower effect with the vaccine. She would like to file an official report with VAERS she wants to receive the information she needs about the vaccine through Pfizer and move forward. She contacted the CDC and usually with adverse effects Pfizer uses the reports of the vaccine. If she has need or medical assistance needed or she doesn't know reimbursement billing. If a medical fee was incurred. She said she had to get a chest x-ray on an unknown date with unknown result and it was an emergency she had to go to the doctor which was a medical expense. She wanted to know if she will be refunded. There is compensation on the FDA's website. On the website from the CDC that says Pfizer has compensation for reaction for the shot for medical expenses. She was informed that she would have to submit a written request to the legal department by mail. She repeatedly asked for a direct phone number for the legal department. She stated her lawyer would not know how to file the claim she would be mailing to them and asked if there is a website to know how to file the claim. Her legal papers. She stated Pfizer cannot be sued they are covered by the government. She wanted to know how effective is it to prevent her from catching covid and stated "the lady just read the statement that people who are immunocompromised have a lower effect with the vaccine". The event was reported as medically significant and life-threatening and patient stated that it had caused her for a physician visit. The patient recovered from anaphylaxis on an unspecified date in 2021.
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| 53 | 2021-05-15 | lymph node swelling, lymph node pain |
Sore arm as site, then chills, and Headache, and feeling of unwell. Then ache joints. Lost of app...
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Sore arm as site, then chills, and Headache, and feeling of unwell. Then ache joints. Lost of appetite and nasuea. and fatigue. Headache, and feeling of unwell ache joints lasted about 24 hour. Lost of appetite lasted about 3 days, Fatigue still have at day 6. Left arm lymph nodes started hurting and swollen about 48 hours after and lasted for 3 days.
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| 53 | 2021-05-19 | peripheral swelling, swelling face |
Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching ...
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Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching in face and neck; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 17:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included severe back issues and "I have had 6 back surgeries", allergy to all Nsaids. The patient previously received bnt162b2, dose 1 administered in Arm Left on 16Mar2021 08:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Concomitant medications included hydrocodone, cefixime (FLEXERIL [CEFIXIME]), buprenorphine hydrochloride (BELBUCA), atorvastatin, clarithromycin, omeprazole, tinidazole (OTC-HP) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of feet, legs, hands, arms and face, itching in face and neck on 07Apr2021 02:00 with outcome of recovered in 2021. Therapeutic measures taken to all events included Benadryl and prescribed EpiPen. The events were assessed as medically significant. The events resulted in Emergency room/department or urgent care visit. It was reported as: Swelling of feet, legs, hands, arms and face as well as itching in face and neck after about 8 hours of receiving 2nd dose. 1st dose was unremarkable. The lot/batch number has been requested.
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| 53 | 2021-05-19 | peripheral swelling |
pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F...
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pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F; a very strong headache; sore throat; The arm is very hot and swelling; The arm is very hot and swelling; pain in the back, neck and everything; pain in the back, neck and everything; shortness of breath; My eyes are so hot and burning; earache; she is not feeling very well; she had a really sore arm in the area of the shot; her head is foggy this morning and all day; This is a spontaneous report from a contactable consumer. A 54-year-old female patient (Age at time of vaccination 54 years) received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 04May2021 at 16:00 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunization. Medical history included back injury, neck injury, Knee Surgeries, 2 Bulging Discs, Heel Spurs and Sciatic all on the left ongoing since 2010 and Covid-19 on 29Mar2020. The patient's concomitant medications were not reported. The patient experienced pneumonia, i've been very very sick, body ache, chills, nausea, so tired/very exhausted, fever 99.3f, a very strong headache, sore throat, the arm is very hot and swelling, pain in the back, neck and everything, shortness of breath, my eyes are so hot and burning, earache, she is not feeling very well, she had a really sore arm in the area of the shot and her head is foggy this morning and all day all on 05May2021. Consumer reported "Since this morning I've been very very sick. I'm sick. I have body ache, chills, nausea, so tired, fever 99.3F, a very strong headache, sore throat. The arm is very hot and swelling. I had Tylenol this morning nothing is working. The body ache is so horrible, pain in the back, neck and everything. I had covid on march 29 last year, I had pneumonia. I have lingering issues, body ache and pain, I still get very tired, shortness of breath; I feel like it's coming back after getting the vaccine. My eyes are so hot and burning, you know the sensation when you have a fever. Commented how she felt like she was getting covid again after getting the vaccine. Yesterday, 04MAY2021, she was vaccinated with the Pfizer Covid Vaccine. States it was her first dose and she is having a lot of side effects. Her temperature is 99.2, she has body aches, earache, headache, a little bit of shortness of breath, very tired, very exhausted and she is not feeling very well. She is wondering if this is a normal reaction for the first vaccine? States it feels like when she had Covid. Clarifies at she was fine last night other than she had a really sore arm in the area of the shot and it is really hot, like if she has a fever in the area. States at 9:30-10:00 a.m. this morning she started having a headache, chills, and nausea. She took a hot shower, and had some tea and took Tylenol. It is progressing worse and worse. States she has body aches and fever getting warmer and warmer, and her throat feels a little bit sore. States all of them are getting worse. She is staying home and laying down not trying to do a lot, drinking water and staying hydrated. States she spoke to a friend and she said she is not supposed to get these side effects with first one. Her body aches are horrible, it feels like when she got the virus, all the aches and pains. Her head is foggy this morning and all day, and she has issues with pain all over, so much body aches. States she is reporting her side effects and she read the side effects but it seems like when she had Covid last March and she is still going through a lot of issues with it, the pain Covid left her with. States she did a Covid test, and she had antibodies, but this feels like the virus again. States she has the same symptoms as when she got the virus. Treatment: Took 2 Tylenol and nothing seems to help. UPC and Expiration: Unknown Lot: 110856. Caller states the UPC and Expiration got erased because she has had it for awhile. Tylenol Rapid Release 500mg.Caller states she took a hot shower, and had some tea. Caller states she is staying home and laying down not trying to do a lot, drinking water and staying hydrated. The outcome of the event pneumonia was unknown. Outcome of all the other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 54 | 2020-12-31 | swelling | Raised red area, that did not itch but became a circle of scabs |
| 54 | 2021-01-04 | anaphylactic reaction |
Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vacci...
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Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vaccine same date product received; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 12:30 PM on 18Dec2020 at single dose for COVID-19 immunization, and first dose of other Pfizer vaccine same date product (other vaccine same date lot number: elt9899) on right deltoid on 18Dec2020 for unknown indication. Medical history reported as none. Concomitant medication included vitamin C and colecalciferol (VITAMIN D). The patient experienced anaphylactic reaction at 12:30 PM on 18Dec2020 requiring two doses of epinephren to control. still having issues, resulted in: Doctor or other healthcare professional office/clinic visit, Hospitalization in Dec2020. days hospitalization: 1. The patient received treatment: 2 doses of epinephrine, solumedrol, benadryl, IV and O2 for event anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was not recovered. Lot/Batch and Expiration date has been requested.; Sender's Comments: The information available in this report is limited and anecdotal and does not allow a medically meaningful assessment of the case. There is a plausible temporal association between vaccines administration and onset of the reported event. It is unclear what is the nature of the vaccine co-administered with BNT162b2. Currently no information is available on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
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| 54 | 2021-01-04 | swelling, lymph node swelling |
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided...
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Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
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| 54 | 2021-01-05 | axillary mass |
LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION ...
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LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION , WENT TO WALK IN AND WAS PRESCRIBED STEROIDS AND ANTIBIOTIC, NO IMPROVEMENT AS OF 2 DAYS LATER
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| 54 | 2021-01-05 | c-reactive protein increased, lymph node swelling |
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA...
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PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
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| 54 | 2021-01-05 | lymph node swelling |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-05 | swelling face |
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ...
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Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
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| 54 | 2021-01-05 | swelling face |
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel...
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20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
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| 54 | 2021-01-07 | lymph node swelling | Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination |
| 54 | 2021-01-07 | swelling face |
I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous repo...
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I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergies to azithromycin and compazine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020, the patient stated she woke up 6 hours after the vaccine with significant swelling in her face. It did not affect her breathing. She took 50 mg Benadryl . The swelling was gone 4 hours later. The clinical outcome of swelling in her face was recovered on 29Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-01-07 | swelling, swelling face |
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati...
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At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
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| 54 | 2021-01-09 | lymph node swelling |
15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and v...
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15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and very swollen arm pit in the arm where i was vaccinated, today is day 2 of swollen painful arm pit.
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| 54 | 2021-01-10 | anaphylactic reaction |
10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was ...
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10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.
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| 54 | 2021-01-10 | peripheral swelling |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-11 | lymph node swelling |
Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment:...
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Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment: Tylenol 325mg (650mg Q4hrs) followed by Naproxen 250mg (Q12hrs), lots of fluids and rest Time Course: 2 days
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| 54 | 2021-01-12 | swelling face |
Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noti...
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Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noticed some swelling, pt was able to maintain the airway. Pt was able to stay monitor sx which resolved the next day.
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| 54 | 2021-01-13 | lymph node swelling, lymph node pain |
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within...
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I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
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| 54 | 2021-01-13 | lymph node swelling | Chills , body aches, fatigue, swollen lymph nodes in right axilla, throat, and under right clavicle |
| 54 | 2021-01-13 | lymph node swelling |
Axilla lymph node swelling of the vaccinated arm. Swelling began the day after vaccination. Reporte...
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Axilla lymph node swelling of the vaccinated arm. Swelling began the day after vaccination. Reported to Employee Health 2 days after vaccination and area measured 70mm at that time. No tenderness noted to palpation. Patient is taking ibuprofen. Encouraged to follow with PCP if swelling continues.
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| 54 | 2021-01-13 | swelling | Systemic: swelling on entire left side of body |
| 54 | 2021-01-14 | lymph node swelling |
Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vacci...
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Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vaccination which resolved by day 2. No medical treatment needed at this time.
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| 54 | 2021-01-14 | swelling face |
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,...
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1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
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| 54 | 2021-01-15 | lymph node swelling |
Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours....
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Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours. Large swollen right supraclavicular lymph node noticed at 72 hours post injection. Painful and warm to touch approx size golf ball. Entire right clavicle swollen and painful.
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| 54 | 2021-01-18 | lymph node swelling, swelling |
Arm sore at injection site for a few days. I noticed several days later that my neck (part between ...
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Arm sore at injection site for a few days. I noticed several days later that my neck (part between neck & shoulder) was swollen. I had a few lumps. I had swollen lymph nodes.
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| 54 | 2021-01-18 | lymph node swelling |
Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2...
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Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2 along with rapid heart beat, increased body aches, pounding heart and sweating. Symptoms lessoned in the morning. Fever returned the next evening (Friday 1/15). Cleared by Saturday except for tiredness. Entire episode completed by Saturday morning 1/16/21. No hospitalization or MD visit. Would have visited my Primary MD, but they referred me to the organization administering the vaccine. Vaccine was given out at work, there isn't a medical clinic available for employees.
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| 54 | 2021-01-18 | swelling, lymph node swelling |
Severe Headache began on Sunday 1/17/2021, then Monday 1/18/2021 I developed Left axillary lymph nod...
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Severe Headache began on Sunday 1/17/2021, then Monday 1/18/2021 I developed Left axillary lymph node edema and left groin swollen lymph node.
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| 54 | 2021-01-19 | peripheral swelling | Sore right arm where I received the shot. Swelling and soreness in my shoulder. Sore neck. |
| 54 | 2021-01-19 | swelling face |
Swelling in my face. I went to the ER on Saturday Morning 1/16/2021 at 10;30 am. I was put on Predni...
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Swelling in my face. I went to the ER on Saturday Morning 1/16/2021 at 10;30 am. I was put on Prednisone and sent home. The swelling was due to too many antibodies in my system.
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| 54 | 2021-01-19 | swelling face |
Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after re...
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Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after receiving vaccine.
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| 54 | 2021-01-20 | lymph node swelling |
Pain & swelling in left lymph node under left arm. Noticed it Dec. 23, 2020, saw healthcare provide...
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Pain & swelling in left lymph node under left arm. Noticed it Dec. 23, 2020, saw healthcare provider Dec. 28, it had not gotten better. I was to watch it. Pain eventually went away Jan. 4, 2021. Received 2nd covid vaccine Jan. 6, 2021.
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| 54 | 2021-01-20 | peripheral swelling |
sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, ...
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sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, and low grade temperature. Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
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| 54 | 2021-01-20 | swelling | Swelling in axilla |
| 54 | 2021-01-21 | anaphylactic reaction |
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ...
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It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
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| 54 | 2021-01-21 | lymph node swelling | SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES |
| 54 | 2021-01-21 | swelling | redness, swelling and slight itchiness to left arm |
| 54 | 2021-01-24 | lymph node pain |
Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lym...
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Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lymph nodes under right arm and neck. Tender right breast as well. Symptoms from the first night after the second vaccine and still 13 days later.
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| 54 | 2021-01-24 | peripheral swelling |
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu...
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On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/arm and neck. clicking in the joint with rotation movement. spoke with Director of Rehab and advised to contact and seek medical care. Call placed to PCP 1/23/21 with office closed for the weekend. due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. spoke to company for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
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| 54 | 2021-01-24 | peripheral swelling |
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm...
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Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
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| 54 | 2021-01-24 | swelling |
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu...
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On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
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| 54 | 2021-01-26 | lymph node swelling | Large amount of swelling in my left armpit |
| 54 | 2021-01-27 | lymph node swelling |
The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to...
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The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to eyelid and side of face. This prompted a visit to urgent care and urgent care sent the patient to the ED for stroke rule-out. The ED did not believe patient was experiencing a stroke and administered 10 mg of IM decadron. The patient's symptoms resided overnight but the next day developed red bumps all over upper palate of mouth. The patient went to her PCP which did not test for strep at this time. The red bumps developed into ulcers with white heads and the patient went back to the PCP which performed a rapid strep test which was negative. The PCP was concerned for mono due to lymph node swelling. The patient's palate has improved slightly but they still feel fatigued.
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| 54 | 2021-01-27 | lymph node swelling |
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty ly...
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She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
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| 54 | 2021-01-27 | swelling face, swelling |
Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to...
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Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to work. Was placed on 3 days of prednisone to decrease the swelling. Prednisone did decrease the swelling. Spoke with my primary doctor on the phone as it was after hours by the time I called him who prescribed the prednisone.
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| 54 | 2021-01-28 | lymph node swelling |
pt states she has sore left arm around the injection site and looks like she had two injection marks...
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pt states she has sore left arm around the injection site and looks like she had two injection marks. Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
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| 54 | 2021-01-30 | swelling | Pain , swelling , fatigued , sleeping |
| 54 | 2021-01-31 | lymph node pain, lymph node swelling |
Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sens...
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Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling, Lymph node swelling and pain.
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| 54 | 2021-01-31 | swollen extremities |
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ...
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body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
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| 54 | 2021-01-31 | peripheral swelling |
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha...
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fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
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| 54 | 2021-02-03 | swollen extremities | Swelling of left axilla, approximately baseball sized starting 2/3/2021 unresolved |
| 54 | 2021-02-03 | swelling face |
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i...
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10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
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| 54 | 2021-02-04 | lymph node swelling, lymph node pain | Swollen/painful left axillary lymph glands. |
| 54 | 2021-02-04 | peripheral swelling |
HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A...
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HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A HEADACHE THAT I COULD'NT GET RELEIF FROM WITHOUT MIGRAINE MEDICATION. DAY 3 I HAD A VERY SORE AND SWOLLEN ARM BUT OTHER SYMPTOMS SUBSIDED. DAY 4 A LITTLE FATIGUE BUT FEELING GOOD.
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| 54 | 2021-02-09 | lymph node pain |
Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes unde...
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Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
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| 54 | 2021-02-10 | lymph node swelling | Headache, slight fever-100, swollen lymph nodes under arm and on neck |
| 54 | 2021-02-10 | swelling |
dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a...
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dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-15 | peripheral swelling |
patient came back in after four or more hours from vaccine administration with complaint of redness ...
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patient came back in after four or more hours from vaccine administration with complaint of redness on her fingertips. no itching, shortness of breathe noted. did assess that patient had additional redness and some slight swelling on the left hand as well. Patient received the vaccination in that arm.
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| 54 | 2021-02-17 | peripheral swelling, lymph node swelling |
Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contact...
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Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contacted MD who prescribed Augmentin 500 mg BID for 10 days. On day 13 after vaccine the swelling went away. Joint pain began on Feb 5th including hips, knees , ankles, wrist and elbows and continues to today. Rash began on both legs (thighs and calf) and hands. Raised rash non pustule red in color. This began approximatly 1 week post vaccine. Right hand began swelling on 2/16/21 with pain and redness. On 2/17/21 swelling increased and increased pain. Pain in right hand and wrist is worse on 2-18-21 (pain scale 6)
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| 54 | 2021-02-18 | anaphylactic reaction | Anaphylaxis |
| 54 | 2021-02-18 | lymph node swelling, peripheral swelling |
swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast...
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swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm, could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
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| 54 | 2021-02-22 | peripheral swelling |
Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had do...
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Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had doses in separate arms and nodules developed after each vaccine)
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| 54 | 2021-02-22 | swelling |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-23 | lymph node swelling |
fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and...
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fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and swelling, swollen lymph nodes in underarms- more pronounced in arm where shot was received.
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| 54 | 2021-02-23 | swelling |
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at...
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Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
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| 54 | 2021-02-24 | peripheral swelling |
I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of...
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I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of the Covid vaccine. I took a dose of pseudoephedrine and the swelling went down. Other reactions were tiredness and injection site pain.
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| 54 | 2021-02-25 | lymph node swelling | Still experiencing Swollen Lymph nodes under arms |
| 54 | 2021-02-25 | peripheral swelling |
Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen...
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Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen currently at day 9)
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| 54 | 2021-02-28 | lymph node swelling | pain above nipple, underarm lympnode is swollen |
| 54 | 2021-02-28 | lymph node swelling |
Armpit on injection side began to form a lump. Swelling progressed into my Left breast. Went into ...
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Armpit on injection side began to form a lump. Swelling progressed into my Left breast. Went into my clinic 2/25/2021 and was examined- was told this was a very common side effect of the vaccine.
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| 54 | 2021-03-02 | swelling face |
Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally...
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Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally low 110/70 but went from 166/86 at 1333 HR 80 02 100%, then BP 163/88 at 1404 HR 74 02 100%, then at 1409 HR 68 BP 175/110 RR24 O2 100% 1405 - 911 called took benadryll at 1330 (25 mg) then again 1349 took 2nd dose of benadryll 25 mg liquid capsules. PT has adverse reactions to epinephrine. 1412 tongue swelling. by 330 pm patient went home prepared to go to ER if anything changed. She walked around in cool air and had hives move around her body. Not shot in upper right arm. It was tasted during injection. Then after the shot reactions kicked in at 20 minutes moving up the right side primarily same as shot side. Arms, chest, and face flush off and on. Swelling moved around.
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| 54 | 2021-03-03 | swelling |
10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressur...
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10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressure. My blood pressure returned to normal within 40 minutes but I had a persistent headache for 19 days. After second dose, the headache returned with greater severity and my PCP had to prescribe a course of prednisone to help reduce the pain. There was no blood pressure change with the second dose. I also had profound fatigue and was in bed for 48 hours after both doses. My current condition is that the headache and swelling has resolved on right side of temple after 3 days on prednisone but I still have selling and pain, though reduced on left side. I also had typical pain at site injection and received both doses in my right arm.
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| 54 | 2021-03-05 | swelling face |
3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right bel...
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3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right below neck was red. Face and red area of chest itchy. Went to quick care, received steroid injection and prescriptions for hydroxyzine and prednisone.
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| 54 | 2021-03-06 | peripheral swelling |
Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to s...
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Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to sloppy handwriting. Days 1-5 with increasing left arm soreness at injection site. Also increasing left wrist joint pain, left elbow joint pain, and left shoulder joint pain. Day 5 and 6 were the worst for joint pain. Very uncomfortable. No fevers. Day 7 with swollen left arm pit and swollen left breast. Arm pit and breast with mild pains and painful to touch or move. Joint pains subsiding . Days 8 -14 continues with the same symptoms of left arm pit swelling, left breast swelling and pains. No skin discoloration and no warmth. No change in swelling , discomfort or pain from days 8-14, but not any better. Can?t wear bra or do yoga.
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| 54 | 2021-03-08 | lymph node swelling | pea size node palpable left clavicular region; almond size node palpable left axillary region |
| 54 | 2021-03-11 | oral herpes |
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou...
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Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
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| 54 | 2021-03-11 | peripheral swelling | Swollen arm, underarm area left side of breast. Weakness in arm, gradually diminishing daily |
| 54 | 2021-03-11 | swelling face, swelling |
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning...
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At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
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| 54 | 2021-03-13 | lymph node swelling |
Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle ...
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Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle and lymph gland in right front collar bone. All symptoms were within hours of administration except the swollen lymph gland. The gland was about 36 hours after administration. I have not pursued treatment at this point.
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| 54 | 2021-03-14 | lymph node swelling | SHORTNESS OF BREATH ,PRESSURE IN CHH EST, NAUSEA, FEVER 101-102, SWOLLEN NECK GLANDS |
| 54 | 2021-03-15 | lymph node swelling |
Swollen, painful neck gland(s) left side of neck. Low grade if any fever but feeling feverish and i...
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Swollen, painful neck gland(s) left side of neck. Low grade if any fever but feeling feverish and indisposed, tired, fatigued. NOT my energized self.
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| 54 | 2021-03-15 | swelling, lymph node pain |
Soreness at injection site on the first day, around 24 hours later developed all over aches, lighthe...
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Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
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| 54 | 2021-03-16 | swelling face | feeling of warmth and swelling on the face |
| 54 | 2021-03-17 | swelling |
c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty ...
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c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report. No resp difficulty. Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85. 12:30pm Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction. All transport to closest ER.
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| 54 | 2021-03-18 | lymph node pain, lymph node swelling |
flu-like symptoms (tired, body aches) for first evening and third evening after vaccination. Also sw...
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flu-like symptoms (tired, body aches) for first evening and third evening after vaccination. Also swelling/tenderness under right arm (lymph nodes?) and right breast that lasted two weeks. Vaccine was administered in left arm. No swelling/tenderness at vaccinated area. I am usually really sore at vaccinated area after flu shots.
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| 54 | 2021-03-18 | lymph node swelling, swelling face |
I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well....
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I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well. Things have been okay until a couple of days ago. I am a fanatic about skincare. I developed a water blister-type rash on the right side of my chin ( not in my mouth). The very next day, my neck started to hurt, and I noticed that my lymph node is swollen on the right side of my neck, just under my jaw. The blisters have crusted over, but my chin and a bit of my cheek are swollen.
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| 54 | 2021-03-19 | lymph node swelling | Under my right arm in my arm pit is hurting and it feels like maybe my lymph nodes are swallen. |
| 54 | 2021-03-20 | swollen extremities |
Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of ...
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Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of injection , chest pain , runny nose, chills, fever, nausea, fatigue, muscle and body aches especially on right side.
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| 54 | 2021-03-21 | lymph node pain |
Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the l...
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Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the left side of the neck. It became increasingly painful on March 19 in the evening (especially after dinner) and overnight (around 3 a.m.) and more painful in the evening on March 20th after dinner. On March 20th, I took 800 mg ibuprofen (4 tablets) at 6 p.m. to relieve the pain. My husband is an Emergency Physician and indicated that is the dose I should take given the pain. At 1:00 p.m. on Sunday the lymphnodes on the left side of the neck began hurting again (excruciating pain) and I again took 800 mg of ibuprofen to relieve the pain. This occurred after having lunch (a burger) at noon. However, at 1:30 p.m. the left side of my face began to feel numb. I had little control of the left side of my mouth and could not close my left eyelid properly. The numbness lasted for about 20 min and then subsided. After 40 min (2:10 p.m.) it felt better and I had a few potato chips left over from my lunch. The numbness started again about 10 min later and lasted about 20 min. The face went numb again the evening of March 22nd for 20 min despite remaining on ibuprofen 3 times a day.
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| 54 | 2021-03-21 | swelling face |
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ...
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When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
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| 54 | 2021-03-22 | white blood cell count increased |
Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia...
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Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia, unable to process thoughts quickly, unable to write legibly, jarbled speech. I was working night shift at the hospital. I was immediately taken to the emergency department. Placed on monitor, labs drawn, neurochecks, EKG. Could not identify some simple pictures, could not recall my co-workers name ( worked with her for 25 years). CT done within 15 minutes of symptoms. MRI completed. Episode lasted approximately 45 minutes.
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| 54 | 2021-03-24 | anaphylactic reaction |
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; ha...
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severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
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| 54 | 2021-03-24 | lymph node swelling |
Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccinati...
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Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccination Nausea and Vomiting. Vomited 4 times over the course of 6 hours. Slept for 5 hours and felt better. Swollen lymph nodes for 3 days after vaccination.
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| 54 | 2021-03-25 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium
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| 54 | 2021-03-25 | lymph node swelling |
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for...
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Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
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| 54 | 2021-03-25 | swelling face |
Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 min...
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Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
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| 54 | 2021-03-25 | swelling | Sore Arm, light swelling. |
| 54 | 2021-03-25 | swelling |
The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have...
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The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have eczema and psoriasis. I took prednisone and the symptoms lasted about 24 hours.
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| 54 | 2021-03-27 | lymph node swelling |
Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of righ...
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Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of right breast x5 days
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| 54 | 2021-03-27 | peripheral swelling |
High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately ...
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High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately after shot. Underarm swelling began at 36 hours after vaccine.
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| 54 | 2021-03-28 | anaphylactic reaction | Acute anaphylaxis - throat closing. Given Benadryl. |
| 54 | 2021-03-28 | lymph node pain | Sensitivity under right ear at lymph glands, no treatment; lasted two days |
| 54 | 2021-03-28 | lymph node swelling | Enlarged lymph node under arm pit size of golf ball |
| 54 | 2021-03-29 | lymph node swelling |
Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever tha...
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Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever that broke in 3 hours, then ongoing fever and chills for 12 hours. 24 Hours later- still have swelling in lymph under left arm where injection was. By 56 hours post injection lymph still swollen and arm very sore.
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| 54 | 2021-03-31 | anaphylactic reaction |
March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Thro...
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March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Throat constricted, rapid heartbeat, hot flash, tingly face. But breathing was normal throughout. Within minutes was given EpiPen, followed by intravenous Benadryl. Then taken to ER to later receive steroids. Was observed in ER for 4 hours, with no reoccurrence of symptoms. Prescription for Prednazone (3 day course) and Benadryl (as needed). Epi Pen if needed. April 1 - Next day, felt totally normal. Slight soreness in arm, and very minor fatigue. was able to work, drive, and go about normal activities.
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| 54 | 2021-03-31 | peripheral swelling, swelling face |
Swelling of face and fingers. Redness to bilateral cheeks with noted mild puffiness. Benadryl 25mg P...
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Swelling of face and fingers. Redness to bilateral cheeks with noted mild puffiness. Benadryl 25mg PO given, another 25mg PO given 15 minutes later. Reported symptoms better. No swelling in face, decreased in hands 15 minutes after second dose of Benadryl.
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| 54 | 2021-03-31 | swelling | Burning lips that day and then swollen, peeling lips for more than 1 mo after |
| 54 | 2021-03-31 | white blood cell count increased |
Thursday, March 18, 2021, 11:00 pm Around 12 hours after the vaccine, I started having stomach cramp...
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Thursday, March 18, 2021, 11:00 pm Around 12 hours after the vaccine, I started having stomach cramps and began having diarrhea. About an hour later (around midnight), I fainted while seated on the toilet and fell face first into the tiled floor. My forehead and mouth/teeth apparently broke my fall and I realized when I came to, I had chipped my two front teeth. There was a good amount of blood and soon after my house mates came to find me, they got me up to lean over the toilet as then I began getting sick and throwing up. They called the paramedics as I kept throwing up. The paramedics tended to me and after two does of an anti-nausea pill, I was able to at least keep a bit of water down. ....
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| 54 | 2021-04-01 | peripheral swelling, lymph node swelling |
Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after ...
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Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after 5 days in my armpit/breast area
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| 54 | 2021-04-01 | peripheral swelling | Swelling, big lump in arm |
| 54 | 2021-04-02 | peripheral swelling |
Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; ar...
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Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
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| 54 | 2021-04-03 | lymph node swelling, swelling face |
Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke...
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Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke up at 2 am and had swelling in face, throat and swollen eyes. Took Pepcid for itchy eyes. In the morning took Benadryl and slept on April 2. Hours later, most of the swelling was gone. Felt like a cold was coming on, running eyes, running nose, sneezing and loss of taste. 48 hours later, cold symptoms linger feeling tired. Still feel some swelling in the glands on neck .
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| 54 | 2021-04-03 | lymph node swelling |
High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection s...
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High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
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| 54 | 2021-04-14 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
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| 54 | 2021-04-23 | lymph node swelling |
pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer...
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pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318 and expiration dates were not reported), via an unspecified route of administration in left arm on 12Feb2021 at 12:30 PM, as single dose for COVID-19 immunisation. The medical history included R hip arthritis and allergy codeine causes nausea and vomiting. The concomitant medication included naproxen, ibuprofen, calcium, vit D and glucosamine. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9261 and expiration dates were not reported), via an unspecified route of administration in right arm on 21Jan2021 at 06:30 PM, at single dose for COVID-19 immunisation. On 13Feb2021 at 12:00 PM, patient experienced pain and swelling of left axillary lymph node. No any other vaccine administered in four weeks. The corrective treatment was not required for the AE. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the patients event was recovering.
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| 54 | 2021-04-24 | lymph node swelling |
pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or l...
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pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or lymph node related; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep6955), via an unspecified route of administration, administered in arm left on 23Mar2021 15:45 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included Hashimoto's from an unknown date. The patient had known allergies to shellfish. The patient had no covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); cyanocobalamin (B 12); magnesium; and cetirizine hydrochloride (ZYRTEC); all were taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 16:30 45-minutes after getting the shot the patient had a sharp pain on the left side of her chest that continually got worse. It seemed muscle or lymph node related - and eventually got to the point where she couldn't easily move without feeling like she was going to pass out from the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included prescription pain reliever and muscle relaxant. The outcome of the events was recovered. The patient did not covid tested post vaccination.
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| 54 | 2021-04-26 | peripheral swelling |
Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THRO...
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Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT FEMORAL, POPLITEAL, POSTERIOR TIBIAL, PERONEAL VEINS and ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT CALF. Admitted for systemic anticoagulation and possible catheter-directed thrombolysis given extent of clot burden and symptoms.
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| 54 | 2021-04-26 | swelling |
Decreased breathing, swelling from head to pelvis, broken blood vessels over entire torso, enlarged ...
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Decreased breathing, swelling from head to pelvis, broken blood vessels over entire torso, enlarged right side of throat, hard to swallow
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| 54 | 2021-04-27 | anaphylactic reaction |
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'...
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Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
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| 54 | 2021-04-29 | peripheral swelling |
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with i...
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04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
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| 54 | 2021-04-30 | peripheral swelling |
brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Diz...
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brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Dizziness; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no known allergies to medications, food, or other products, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4-weeks prior to the COVID vaccine. The patient had no concomitant medications. On 30Mar2021 at 19:00 the patient experienced extreme fatigue and dizziness four hours after vaccination; six hours post-vaccination the patient experienced mild headache, swelling in hands, fever, and joint pain. The patient further reported the next day she had mild hand swelling, severe fatigue, brain fog and mild joint pain. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of extreme fatigue, dizziness, mild headache, swelling in hands, fever, joint pain, and brain fog were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.
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| 55 | 2021-01-02 | swelling face, anaphylactic reaction |
25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itchin...
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25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.
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| 55 | 2021-01-03 | swelling | Arm soreness Swelling Overall body feeling shaky |
| 55 | 2021-01-04 | anaphylactic reaction | Agitation, Sedation, Anaphylaxis, Rash & HYPOtension |
| 55 | 2021-01-04 | lymph node swelling | noted swollen lymph node left armpit area, slightly tender |
| 55 | 2021-01-04 | swelling face |
6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wris...
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6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists. I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not. I was advised to report it. It was bad enough to have been prescribed prednisone
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| 55 | 2021-01-05 | white blood cell count increased |
Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab resu...
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Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab results showed elevated WBC and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from 12/26/20-12/28/20.
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| 55 | 2021-01-06 | lymph node pain, lymph node swelling | Swollen, sore lymph nodes |
| 55 | 2021-01-06 | lymph node swelling |
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ...
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Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
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| 55 | 2021-01-06 | swollen extremities |
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien...
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Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
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| 55 | 2021-01-07 | lymph node swelling, lymph node pain |
1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM ...
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1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM Swollen/Painful lymph nodes -left axilla
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| 55 | 2021-01-07 | lymph node swelling |
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph...
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Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
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| 55 | 2021-01-07 | oral herpes |
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around ...
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At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.
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| 55 | 2021-01-07 | swelling |
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ...
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Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
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| 55 | 2021-01-08 | anaphylactic reaction | Patient felt tongue swell, and then her throat started to close. -Anaphylaxis |
| 55 | 2021-01-10 | axillary mass |
The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I ...
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The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I broke my wrist last year and the ache in that wrist was awful. Motrin helped but this persisted throughout the day. General feeling of being unwell for the whole day and evening. The second day after the shot I woke up feeling better but in my armpit on the arm I received the shot it felt like I had a lump in my arm pit and it is sore. This is still there today, the third day after the shot.
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| 55 | 2021-01-12 | lymph node pain |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-12 | lymph node swelling, lymph node pain |
On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node ...
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On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node in my neck on the right side. The lymph node was about the size of a large gumball. The next day I started having pain in the lymph nodes of my arm pit on the right side. The symptoms are still present six days later and I now have some swollen and tender lymph nodes in the antecubital area of the same arm. I am scheduled to get my second dose on 1/21/21. I have not had any other side affects that I know of other than feeling a little tired and mild headache on and off but that didn't seem unusual for me. The lymph node in my neck seems to be getting a little smaller as of today 1/13/21.
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| 55 | 2021-01-13 | peripheral swelling, lymph node swelling |
Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; mu...
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Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-13 | peripheral swelling | Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles |
| 55 | 2021-01-14 | lymph node pain |
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r...
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Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
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| 55 | 2021-01-14 | swelling |
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report...
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Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
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| 55 | 2021-01-17 | peripheral swelling, swelling face |
12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of...
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12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of SoluMedrol 125mg and sent to the emergency room. 12/27/20 Presents feeling sick, body aches, chills, nausea, rash and vomiting. SOB better. Given Zofran and IV fluids in ER. D/C home with prednisone and Zofran. D/C dx: Acute allergic reaction, Nausea and vomiting
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| 55 | 2021-01-18 | lymph node swelling |
55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2...
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55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2 Fahrenheit, sore throat, and some left axillary lymph node swelling. She also had some erythema and edema to the vaccination site. She received this vaccination on January 11. Her symptoms started January 12. On January 14, 2021, patient returned to urgent care for worsening erythema and discomfort at injection site. Patient was given supportive care and discharged home.
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| 55 | 2021-01-18 | lymph node swelling |
Lymphadenopathy in right arm with intense pain, also intense pain on the back from shoulders to the ...
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Lymphadenopathy in right arm with intense pain, also intense pain on the back from shoulders to the waist. Arthralgia, specifically on both ankles, fever , dizziness, and nausea. treated with acetaminophen and rest.
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| 55 | 2021-01-20 | lymph node swelling | Fatigue, nausea, headache, right axillary lymphadenopathy |
| 55 | 2021-01-20 | swelling face |
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG...
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HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
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| 55 | 2021-01-21 | lymph node swelling, swollen extremities |
Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at th...
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Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at this time) Fever 100.5-100.9 x 30 hours Severe muscle and bone aching x 36 hours Chills x 18 hours
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| 55 | 2021-01-21 | swelling face, swelling |
I pretreated with zyrtec, pepside and benedryl. I had swelling on the second day in the left , my no...
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I pretreated with zyrtec, pepside and benedryl. I had swelling on the second day in the left , my nose, cheeks that stayed for days.
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| 55 | 2021-01-21 | swelling |
Left Groin lymph node inflammation 12 -23 - 2020 worsening over 3 weeks antibiotics started on ...
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Left Groin lymph node inflammation 12 -23 - 2020 worsening over 3 weeks antibiotics started on 1/12/2021
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| 55 | 2021-01-22 | lymph node swelling |
After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, ...
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After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, noticed trouble swallowing, coughed up some banana , took a drink of water. I then felt my lymph nodes in my neck were swollen. Waited another 15 min in the parking lot, went back into the to use the bathroom and to make sure symptoms were not progressing. At this point it had been approx 45min post vaccine and no other symptoms. 24 hrs later symptom had resolved.
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| 55 | 2021-01-24 | axillary mass |
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S...
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On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
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| 55 | 2021-01-24 | oral herpes |
viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (...
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viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 55 | 2021-01-25 | lymph node swelling, lymph node pain |
lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red a...
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lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
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| 55 | 2021-01-25 | swelling, swelling face, lymph node swelling |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-26 | lymph node swelling |
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul...
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Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
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| 55 | 2021-01-27 | lymph node pain |
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontane...
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Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.
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| 55 | 2021-01-27 | peripheral swelling |
Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hy...
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Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hydroxyzine about 6 hours apart. Symptoms resolved and did not return.
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| 55 | 2021-01-27 | swelling |
Swelling behind left ear. Mastoiditis ruled out by CT; This is a spontaneous report from a contactab...
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Swelling behind left ear. Mastoiditis ruled out by CT; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took tetracycline hcl (MANUFACTURER UNKNOWN) and thimerosal (MANUFACTURER UNKNOWN); both on unknown dates for unknown indications and experienced drug allergy. On 12Jan2021 at 06:00, the patient experienced swelling behind left ear. The event required a visit to the emergency room and physician's office. A computed tomogram in Jan2021 ruled out mastoiditis. The patient was started on antibiotics to see if the swelling would resolve. The clinical outcome of the swelling behind the left ear was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 55 | 2021-01-28 | lymph node swelling |
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi...
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Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
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| 55 | 2021-01-28 | swelling face | Dizziness for 4 days Swollen face Increased Heart Rate and Blood Pressure |
| 55 | 2021-01-30 | lymph node swelling |
Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceede...
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Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceeded on to high temp for 24 hours and enlarged lymph node interfering with activities of daily living.
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| 55 | 2021-01-31 | lymph node swelling, swollen extremities | edema lymph node left axilla , nausea, |
| 55 | 2021-01-31 | lymph node swelling, swelling |
The day after the vaccination I had redness around my whole shoulder and arm. On the third day I dev...
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The day after the vaccination I had redness around my whole shoulder and arm. On the third day I developed swelling of my shoulder and neck with horrible pain when I breathe. I went to urgent care and had an x-ray which was clear and they were treating me for myalgia with Motrin. I refused any narcotic pain medication or a Toradol shot. The pain never stopped on the 19th I went to Work Force Safety and reported it and I was examined by the nurse practitioner who saw all the swelling and the pain that I was in. That nurse practitioner told me if it wasn?t better in a few days to go to the emergency room to be examined. On January 23 , I developed swelling and pain went underneath my armpit it?s a burning pain that?s constant since the third day after my injection. My blood pressure was 153/104 and I was having nausea and not feeling well at all. On January 25 the pain and swelling were still there I went to work for a few hours and I went to the emergency room. They gave me lidocaine patch and Zofran for the nausea my blood pressure was 159/103 and I had an ultrasound to rule out a blood clot there was no blood clot but there was lymphadenopathy under my arm hurt and swelling and inflammation around the shoulder. The chest x-ray showed left pleural effusion / Pneumonia. My oxygen saturation was 93 and they wanted to admit me but I am a single mom with a new diabetic 14-year-old at home so they let me go home with a pulse oximeter and a prescription for doxycycline For 10 days. They called me the next day from the emergency room to follow up with a pulmonologist and cardiologist. On January 28 I saw the pulmonologist who did an ultrasound in his office and saw the fluid on my left lung. He said that most likely because the technique of the injection was so high in my shoulder that they probably had a nerve and I did have the swelling in the lymphadenopathy and all the pain and it hurt when I breathe so I wasn?t breathing correctly and I was splitting my arm against me and that?s how I probably developed plural effusion and pneumonia. I am following up with him on February 4. I still have shortness of breath and my oxygen saturation is 93. I am also on two inhalers that the pulmonologist ordered.
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| 55 | 2021-01-31 | peripheral swelling |
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and ...
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After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened With: SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9 hours FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen 1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours
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| 55 | 2021-02-02 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 55 | 2021-02-03 | lymph node swelling, lymph node pain |
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, abou...
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I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, about 12pm I start having side effect: Left Arm sore, hurt to lift (arm that was injected) Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor. Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad. I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness. As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night On Friday January 29th felt much better and arm hurt less to lift it. On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided Sunday January 31, glands under arm are better, much less sore Monday February 1st glands under arm, back to normal
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| 55 | 2021-02-03 | peripheral swelling |
After an hour and a half to two hours after injection, I began to have an allergic reaction but it w...
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After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
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| 55 | 2021-02-05 | lymph node swelling |
All over achiness, low grade fever (100), swollen lymph nodes right side of neck and above collar bo...
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All over achiness, low grade fever (100), swollen lymph nodes right side of neck and above collar bone on right side
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| 55 | 2021-02-05 | lymph node swelling |
Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of br...
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Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of breast
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| 55 | 2021-02-07 | swelling |
Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe...
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Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
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| 55 | 2021-02-08 | swelling face |
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset....
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Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
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| 55 | 2021-02-08 | swelling | SWELLING, REDNESS, PAIN AT SITE, VERY TIRED |
| 55 | 2021-02-10 | lymph node swelling, lymph node pain | My lymph node under my left arm is swollen to the size of a big lemon & it hurts. My bra bothers it. |
| 55 | 2021-02-13 | lymph node swelling | Swollen glands in neck |
| 55 | 2021-02-14 | lymph node pain, lymph node swelling |
At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fev...
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At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fever of 102. Body aches and pains. Had to put on extra clothes and blankets. Went to work in am but had to leave early due to ongoing body pains and fever of 101. Also, inflamed lymph node in axilla of shot arm- very painful. Felt better by Sat late morning. Please note I am strawberry blonde as is coworker who had same response. Other individuals with us with very mild symptoms.
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| 55 | 2021-02-14 | lymph node swelling |
Left supraclavicular adenopathy of significance including virchow's nodes. (Also a fever, that was ...
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Left supraclavicular adenopathy of significance including virchow's nodes. (Also a fever, that was expected, of 100.7.)
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| 55 | 2021-02-17 | anaphylactic reaction |
anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A ...
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anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation. Medical history included severe peanut allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy. She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021. She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-02-17 | lymph node swelling, lymph node pain |
lymph node soreness size of small orange/enlarged lymph node; Fever of 103.4/Day 3 still temp of 100...
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lymph node soreness size of small orange/enlarged lymph node; Fever of 103.4/Day 3 still temp of 100; lymph node soreness size of small orange; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) on her left arm, via an unspecified route of administration on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included asthma. Patient previously took codeine and experienced allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 (first dose). The patient experienced Fever of 103.4 lymph node soreness size of small orange on 30Jan2021 at 01:00AM. Day 3 still temp of 100 and enlarged lymph node. The patient also had a covid test on 24Jan2021 which tested negative.
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| 55 | 2021-02-17 | lymph node swelling |
Lump under the armpit (possible enlarged lymph node) for about 5 days. Intense heartburn or chest ...
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Lump under the armpit (possible enlarged lymph node) for about 5 days. Intense heartburn or chest tightness 3 days after the vaccination - unsure if it's related to vaccine. Resolved overnight.
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| 55 | 2021-02-18 | swelling | High degree of swelling |
| 55 | 2021-02-20 | lymph node swelling |
12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 P...
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12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 PCM; ball of fluid with hard lymph nodes. Put on antibiotics for 14 days. 1/11 mammogram; negative/zero abnormalities. Lymph nodes WERE VERY enlarged; verified.
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| 55 | 2021-02-21 | lymph node pain, lymph node swelling |
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H...
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FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
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| 55 | 2021-02-21 | lymph node swelling |
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little...
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Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
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| 55 | 2021-02-23 | lymph node swelling |
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me...
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Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
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| 55 | 2021-02-26 | lymph node swelling | Swollen lymph node (R axillary) burning sensation in armpit/radiating down arm, fatigue, joint pain. |
| 55 | 2021-02-28 | swelling |
Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved i...
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Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved inn48 hours
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| 55 | 2021-02-28 | peripheral swelling | severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room. |
| 55 | 2021-03-01 | swelling face |
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness...
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Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
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| 55 | 2021-03-05 | lymph node swelling, lymph node pain, peripheral swelling |
Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Inc...
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Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Including fever. Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm. Left arm swelling very minimal but right nodes continue to get worse 3 days in. Today
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| 55 | 2021-03-06 | lymph node pain |
Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. ...
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Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. Resolved after taking an antihistamine about an hour later. Took 1 Alavert. Next morning started feeling generally unwell with body aches, fatigue, mild chills. Took Tylenol or Advil every 4-6 hours for 36 hours after injection which helped symptoms. Axillary lymph nodes on injection side became tender and sore in about 24 hours after injection and lasted about a week before resolving.
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| 55 | 2021-03-06 | lymph node swelling | Bump under left arm pit,- very sore, body aches |
| 55 | 2021-03-07 | lymph node swelling, swelling |
1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was sch...
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1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was scheduled for 3:40 PM, but probably didn't receive until 4:20 PM. At night, I had insomnia. The next morning, my fever went up to 101.2, I had swelling of the neck, my arm @ injection site, swollen lymph nodes in my left armpit, body aches, occasional stabbing pains in random places (back, arm, leg, etc.), extreme fatigue, it lasted for 1.5 days and then the fever dropped to 99. By the second day the fever was gone, body aches gone & only thing left on day 2 is swollen lymph nodes in arm pit, arm soreness at inoculation site, and fatigue. Day 3 slight fatigue, a bit of soreness in arm and armpit.
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| 55 | 2021-03-07 | lymph node swelling | Swelling of lymph nodes in neck by the throat and sinuses feel stuffy. Feel tired. |
| 55 | 2021-03-08 | peripheral swelling |
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate...
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Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
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| 55 | 2021-03-10 | lymph node swelling | Swollen lymph nodes from left breast and under my left arm pit and hot to the touch. |
| 55 | 2021-03-10 | peripheral swelling, swelling |
Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next d...
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Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next day. Tingling in the mouth for about an hour and a half on the same day.
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| 55 | 2021-03-12 | lymph node swelling | swollen lymph node in the left armpit received the vaccine in the left arm. |
| 55 | 2021-03-13 | lymph node swelling |
Headache and fatigue beginning the evening of March 13th, Early the morning of the 14th, woke to my...
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Headache and fatigue beginning the evening of March 13th, Early the morning of the 14th, woke to myalgias and body aches. Low grade fever. Swollen lymph node in right shoulder. Some relief with Motrin.
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| 55 | 2021-03-14 | lymph node swelling |
Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fe...
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Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fever,headache.
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| 55 | 2021-03-14 | swelling face |
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness...
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About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
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| 55 | 2021-03-16 | swelling |
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v...
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4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
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| 55 | 2021-03-17 | swelling |
Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, staye...
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Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue. Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips. Lisinopril d/c'd on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak. Allergist recommends no further COVID vaccines.
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| 55 | 2021-03-18 | swelling face |
AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING R...
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AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING RESOLVED ABOUT 15 MINS AFTER ONSET AND THE FACIAL SWELLING ABOUT AN HOUR AFTER ONSET.
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| 55 | 2021-03-19 | lymph node swelling, lymph node pain |
The day following the vaccine, I began to feel pain underneath my arm pit. The next morning when I ...
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The day following the vaccine, I began to feel pain underneath my arm pit. The next morning when I woke up, the lymph nodes underneath my arm were swollen and painful.
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| 55 | 2021-03-19 | lymph node swelling |
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai...
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With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
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| 55 | 2021-03-19 | swelling, swelling face |
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and ...
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Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
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| 55 | 2021-03-20 | lymph node swelling |
enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This...
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enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This is a spontaneous report from a contactable other health care professional. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0142), intramuscular, administered in Arm Right on 12Jan2021 08:00 AM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249) intramuscular, administered in Arm Right on 29Jan2021 08:00 AM as single dose for COVID-19 immunisation. Medical history included breast cancer, restless legs syndrome, insomnia, hypertension, PALB2, CKD, NF1, and few known allergies to codeine, Morphine and Mollusks from an unknown date and unknown if ongoing. The patient's concomitant medications included Lasix, Kdur, anastrozole, requip, Metoprolol, trazadone, nortriptyline, melatonin, MV, Vit C. On 23Jan2021 04:00, the patient experienced enlarged anterior axillary lymph node and reported my breast tumor grew to size of golf ball in six months on an unspecified date. approximately 7-10 days following first injection on 12Jan2021 noted an enlarged anterior axillary lymph node. I watched it for approximately one week. It was slightly larger but definitely not smaller Received 2nd covid vaccine on 29Jan2021. notified provider on 01Feb2021 ordered US done 09Feb2021. I have PALB2 mutation, breast cancer post chemo, a RUL and LLL lung nodules. I am being told it is from my first Covid vaccine and to recheck in two months. My breast tumor grew to size of golf ball in six months. I am unsure of exact date it became enlarged or what day i noticed it. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events Not recovered.
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| 55 | 2021-03-21 | lymph node swelling |
48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after va...
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48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after vaccination severe stomach cramps/pain after eating spciy food 4 days after vaccine armpit of vaccine site arm (left) had dark/purpleish discolored area about 5 cm and moderate swelling . Discoloration has now resolved, slight swelling remains.
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| 55 | 2021-03-22 | swelling face | face swelling, rash on cheeks, eyes,nose, sore arm, |
| 55 | 2021-03-23 | axillary mass |
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around...
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3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
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| 55 | 2021-03-23 | swelling face | Numbness and swelling in left cheek and under chin, feeling faint. |
| 55 | 2021-03-23 | white blood cell count increased |
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ...
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Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
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| 55 | 2021-03-24 | peripheral swelling |
Patient's hands started swelling about five minutes after receiving vaccine. No signs of allergic re...
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Patient's hands started swelling about five minutes after receiving vaccine. No signs of allergic reaction on trunk or airway. Patient took 50 mg of diphenhydramine and was observed in the pharmacy for 30 minutes. No worsening of symptoms over that time. Reported event to physician. Followed up with patient two hours later, no worsening of symptoms and swelling was almost gone.
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| 55 | 2021-03-24 | swelling face, swelling, peripheral swelling |
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat...
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Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
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| 55 | 2021-03-25 | anaphylactic reaction |
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started...
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pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
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| 55 | 2021-03-25 | lymph node swelling |
Achiness through upper torso plus a lump in arm pit of left arm. Rubbed self down with arnicare f...
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Achiness through upper torso plus a lump in arm pit of left arm. Rubbed self down with arnicare for achiness the day following shot, cleared up that situation within. Iced the lump at the same time but still tender on 2nd day continue to ice off and on.
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| 55 | 2021-03-25 | lymph node swelling |
INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE A...
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INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE ARM AT INJECTION SITE DAY 2, FATIGUE DAY 2, NAUSEA AND EASILY DEHYDRATED DAY 2-5 SWOLLEN LYMPH NODES DAY 8-10 ON RIGHT SIDE ONLY
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| 55 | 2021-03-25 | swelling |
Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach a...
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Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach and was throwing up; Pain; sick on my stomach and was throwing up; Headache; Hips, legs and neck is a little swelled; my hip down were pain; arm was very sore; could not move arm; arm was very sore; could not move arm; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of BNT162B2 (pfizer-biontech covid-19 vaccine, Formulation: solution for injection, lot number: EL3246; Expiration Date: 30Apr2021) via intramuscularly on right arm as single dose on 14Jan2021 for covid-19 immunisation. The patient received first dose on 24Dec2020 and she didn't have any reaction, no nothing. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient work at the hospital in the kitchen and don't have any health issues before, none. Laboratory data included, Multiple blood work, 3 MRIs, Chest X-ray, EKG, EMG. On 15Jan2021, after receiving second dose patient stated, it's been almost a month, she had all kinds of trouble, in walking, hips, legs and neck is a little swelled. she had a major headache the last four days, her arm was very sore, she was sick on her stomach, she was throwing up. The next day she could hardly walk. She used a walker. She was out of work and did physical therapy, from her hip down were pain and was hard to walk and it spend like that for a month now and it's now 17Feb2021. Patient hospitalized cause she couldn't walk. She spent six days in a hospital (28Jan2021 to 3Feb2021), they are not sure if it is related to that. They are not even sure what's going on. They can't tell what's wrong. Patient started the treatment with "Gabapentin-300 mg, twice a day, still taking, start date: Consumer stated, " she don't remember. Acetaminophen-codeine 3-1 tab every 6 hours as needed, still taking, start date: Consumer stated, "Last week, I don't know." She was just wondering why she had all these side effects. The outcome of the event she was sick on her stomach was unknown and all of the event was not recovered.
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| 55 | 2021-03-28 | lymph node swelling |
Chills and tiredness the day after on Sunday. Sunday evening noticed the lymph nodes in my armpit of...
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Chills and tiredness the day after on Sunday. Sunday evening noticed the lymph nodes in my armpit of the arm I received the shot in were swollen and sore. Still experiencing it today(Monday).
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| 55 | 2021-03-28 | peripheral swelling |
upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain...
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upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain 600 pm 3/25/2021 swelling of arm, felt the heat on injection area, headache persistence, having heat flashes through the night & morning 9am 3/26/2021 headache comes and goes, arm still the same very sore, heat flashes persistence, dizziness, 3/27/2021 symptoms still all the same, seek medical attention from my primary doctor 3/28/2021 received prescriptions acetaminophen 500mg and meclizine
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| 55 | 2021-03-28 | swelling |
Per EMS, " very mild rash/bumps that began to come up while in observation area. Patient's vitals we...
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Per EMS, " very mild rash/bumps that began to come up while in observation area. Patient's vitals were assessed and within normal limits. No SOB, chest pain, or low blood pressure." She was given oral Benadryl 25 mg to self-administer and reported relief felt.
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| 55 | 2021-03-29 | lymph node swelling, lymph node pain |
Painful and tender area in armpit of the arm that got the shot. Assuming lymph node swollen and tend...
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Painful and tender area in armpit of the arm that got the shot. Assuming lymph node swollen and tender.
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| 55 | 2021-03-29 | swelling |
Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for...
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Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for me to breath at night when laying down to sleep. I also feel heart palpatations, even when laying down and it feels like irregular or racing heart rate, to the extent that I have to sit up and focus my mind on calming my heart rate. I also feel easily out of breath even in doing small activities. I have a lack of energy and I am sleeping a lot and still always feeling tired, I also have brain fog unless I drink a ton of coffee. I have no mental clarity for much of the day. I wonder if I will ever regain my full health prior to getting the shot. I also got really sick about 2 weeks after the shot with a really sore throat and chills and I didn't get better even when taking antibiotics. It's been a few weeks, and I am still not feeling normal.
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| 55 | 2021-03-30 | anaphylactic reaction |
Anaphylaxis, confirmed by ER; This is a spontaneous report from a contactable other healthcare profe...
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Anaphylaxis, confirmed by ER; This is a spontaneous report from a contactable other healthcare professional (HCP). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was unknown), intramuscularly, administered in the left arm on 19Feb2021 at 12:15 PM as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and hydrocodone bitartrate, paracetamol (VICODIN), from which she had known allergies. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 19Feb2021 at 12:15 PM, the patient experienced anaphylaxis, confirmed by emergency room (ER). The adverse event (AE) resulted in a doctor or other HCP office/clinic visit and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of anaphylaxis, confirmed by ER, which included epinephrine, steroids, and antihistamines. The patient recovered from the event on an unspecified date.; Sender's Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.
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| 55 | 2021-03-30 | lymph node swelling |
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec...
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Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
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| 55 | 2021-03-30 | peripheral swelling, anaphylactic reaction |
hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy bey...
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hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy beyond itch; Anaphylaxis; Double vision; Right eye is going cross eyed/Left eye is dropping; Right wrist pain increased dramatically after the vaccine; Throat starting to close/Throat started tightening; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Feb2021 10:00 (Batch/Lot Number: EN6201), at the age of 55 years, as single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 3 years ago, ongoing gastrooesophageal reflux disease diagnosed 4 years ago, ongoing hypertension diagnosed 4 years ago, ongoing food allergy: allergic to eggs, shellfish, dairy/lactose intolerant, ongoing allergies to environmental: standard- hay fever, dust, mold, ongoing allergies to dogs and cats, contrast media reaction (IV contrast CT scan dye- respiratory distress, throat tightens), urticaria, pruritus. She had Covid on 18Dec2020 and "Covid rash it attached her muscular system. She had muscular pain in the wrist and hip on the right side and mild double vision." The patient previously took vitamin k 2 and experienced anaphylactic reaction, Toradol and experienced urticaria, influenza vaccine and experienced rash at the injection site, at the age of 34 years (because she's allergic to eggs). The patient received the first dose of bnt162b2 on 29Jan2021 Lot: EL3247; 9:30 AM; Right arm for covid-19 immunisation and she did not have any symptoms whatsoever with the first shot. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. Vaccination Facility Type: Hospital. Concomitant medications included omeprazole taken for gastrooesophageal reflux disease; lisinopril taken for hypertension; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (INHALERIN) taken for asthma; start and stop date were not reported for all. The patient experienced anaphylaxis on 26Feb2021 with outcome of unknown, throat starting to close/throat started tightening on 19Feb2021 with outcome of recovered, severe rash- latus stranding, purple dots, and hives from face all the way down to toes on 19Feb2021 with outcome of not recovered, double vision on 20Feb2021 with outcome of not recovered, right eye is going cross eyed/left eye is dropping on 20Feb2021 with outcome of not recovered, right wrist pain increased dramatically after the vaccine on 20Feb2021 with outcome of not recovered, hands got very swollen and rash and itchy beyond itch on an unspecified date with outcome of unknown for Hand swelling and recovered for Localised itching. Therapeutic measures were taken as a result of the events: Benadryl, Zyrtec, Pepcid, New glasses for double vision, Prednisone 7 day ween. The patient underwent lab tests which included Hematology test on unknown date with unknown results; Immune markers on 11Mar2021 with unknown results. Clinical course: The patient received the vaccine on 19Feb2021at 10:00 AM and five minutes after, her throat started tightening and they put her in observation for another hour and then her throat felt fine and they let her go. Caller confirmed she was not referring to this occurrence as anaphylaxis. The anaphylactic reaction occurred days later. She mentioned from 19Feb2021-26Feb2021, her symptoms were progressing and then on 26Feb2021, it was full blown out; the actual anaphylaxis was 26Feb2021. Between this, she had severe double vision, severe rash from face all the way down to toes, one eye going cross eyed (right eye), left eye is still drooping. On 20Feb2021, she started having double vision that started with the sunlight and fluorescent lights and the next day she couldn't see anything without double vision, and her eye started going cross eyed. She still cannot see normally now. She is under eye doctor care for that too. The patient was treated with Epi-Pen into leg and then into the Emergency Room. She received 50 mgs of Benadryl and 125 mg of Solu-Medrol IM injection, but still have to give Epi because her throat was still closing. Her airway was intact and no nebulizer treatment needed. The patient reported also that her hands got very swollen and rash and itchy beyond itch. The patient reported that her weight at that point was 204, the she had been on Prednisone for a week, and her weight has gone up to 210 now. After her throat closed on the 26Feb2021, caller reports she gained 7 pounds while on it for one week. Caller stated she was also put on prednisone when she got diagnosed with asthma, reactive airway. She confirmed her throat stop closing immediately after the Epi. The patient was also treated with 25 mgs of Benadryl, Zyrtec, and Pepcid a day. Outcome for throat closing was improved with medication. Outcome for rash was not improved and she is taking medicine to counteract it; itch went away when she took the Zyrtec. Regarding right wrist pain, it increased dramatically after the vaccine. Caller reports it felt like a spiral fracture down the ulna and it started to ache on 20Feb2021, by the next day it hurt a 5 out of 10. By 22Feb2021, she was wearing a splint, it was 8 out of 10, and she felt like she fractured it and it was swollen on the ulnar side. Regarding eye disorder, she is now under the care of an eye doctor for her severe double vision, eye crossing, and eye drooping. The blurred eyes give bad balance and that kind of stuff. The cross eyedness gives her poor peripheral vision and also her depth perception has now been compromised. They say the glasses will fix it. As of 22Feb2021, a new pair of special lenses with prisms were ordered for her. The patient was not hospitalized.
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| 55 | 2021-03-31 | anaphylactic reaction |
anaphylaxis approx. 25 minutes after injection - took 50mg benedryl and recovered within 90 minutes...
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anaphylaxis approx. 25 minutes after injection - took 50mg benedryl and recovered within 90 minutes of injection
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| 55 | 2021-03-31 | lymph node swelling |
I received my shot in right buttocks. After a week the lymph nodes in right groin area were signifi...
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I received my shot in right buttocks. After a week the lymph nodes in right groin area were significantly swollen.
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| 55 | 2021-04-01 | lymph node pain |
Day one after 1st dose: Woke up with joint and muscle pain, headache, chills, low grade fever (up t...
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Day one after 1st dose: Woke up with joint and muscle pain, headache, chills, low grade fever (up to 101.5F). Side effects increased in severity over the course of the day and into the night. Took one 500 mg Tylenol capsule in the afternoon against the headache. Day two after 1st dose: All side effects (above) were completely gone, but lymph nodes in the arm pits were very tender.
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| 55 | 2021-04-13 | swelling |
55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID...
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55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID vaccine. Rash first appeared on L palm, then right palm, then L foot. Rash cleared in approximately 1 week. She endorsed mild pruritis without dyspnea, swelling, wheezing.
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| 55 | 2021-04-14 | lymph node swelling |
2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for...
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2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
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| 55 | 2021-04-14 | lymph node swelling |
Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swol...
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Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
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| 55 | 2021-04-14 | peripheral swelling |
Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Pa...
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Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Patient had her own Benadryl and self administered 25 mg. orally. Swelling began to decrease and BP lowered as well. No presence of hives or SOB. Per Fire Rescue no further evaluation needed. Client released at 12:00pm.
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| 55 | 2021-04-14 | sepsis |
R06.03 - Respiratory distress J18.9 - Multifocal pneumonia K72.90 - Liver failure without hepatic co...
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R06.03 - Respiratory distress J18.9 - Multifocal pneumonia K72.90 - Liver failure without hepatic coma, unspecified chronicity (CMS/HCC) U07.1 - COVID-19 A41.9 - Sepsis, unspecified organism
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| 55 | 2021-04-15 | anaphylactic reaction | Anaphylaxis - throat swelling |
| 55 | 2021-04-24 | anaphylactic reaction |
Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Ca...
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Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Care Professional (reporting on her-self). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP6955 and Expiry date was not re-ported), via an unspecified route of administration on 06Apr2021 13:35 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, fibromyalgia, intervertebral disc de-generation, post-traumatic stress disorder, back disorder all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; gabapentin (GABAPENTIN) taken for fibromyalgia, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia, post-traumatic stress disorder, start and stop date were not reported; naproxen (NAPROXEN) taken for back disorder, start and stop date were not reported. The patient previously 'Incurin' and 'Epitab' and experienced anaphylactic reaction. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that on 06Apr2021 at 13:35, patient had her second BNT162B2 vaccine. she ended up having an anaphylactic reaction was hospitalized and just got out today. She also want to say she have a history of having anaphylactic reaction from three different medication 'Incurin' and 'Epitab'. Patient stated that she had nothing wrong after the first one. Patient is a Nurse but not working right now. she was disabled (Further not clarified if consumer is physically disabled or financially) but she was a nurse. Patient was hospitalized on 06Apr2021. patient stated, she, was better. Her eyes are still swollen but she breathing when she went to hospital. Consumer stated for laboratory work Well in hospital they got lab, not before the vaccine and in the hospital they did lab when she got admitted in the hospital. Patient stated since she got in the hospital she have to take Prednisone for 5 days and Benadryl (treatment) for 5 days. she just got out of the hospital. The outcome of the event Anaphylactic reaction was recovering and for event eyes swollen was not recovered.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.
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| 55 | 2021-04-24 | anaphylactic reaction |
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ...
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felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
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| 55 | 2021-05-07 | lymph node swelling |
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/...
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Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
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| 55 | 2021-05-11 | swelling face |
Extreme Dizziness immediately; Face Swelling; Rapid heartbeat; Joint Pain; This is a spontaneous rep...
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Extreme Dizziness immediately; Face Swelling; Rapid heartbeat; Joint Pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262) (age at vaccination was 55 Years and non-pregnant at the time of vaccination) via unspecified route of administration on 26Jan2021 14:00 in left arm as single dose for COVID-19 immunization. The patient's medical history included Sjogrens Syndrom and high Blood Pressure. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included Losartin 100mg, HCT 25mg. On 26Jan2021, the patient experienced extreme dizziness immediately, face swelling, rapid heartbeat, joint pain. It was unknown whether the patient received any treatment for the events. These events resulted in emergency room/department or urgent care. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information was expected.
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| 56 | 2021-01-03 | swelling face |
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was...
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After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
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| 56 | 2021-01-03 | swelling |
12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is...
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12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol. This has continued beyond 72 hours.
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| 56 | 2021-01-03 | white blood cell count increased, lymph node swelling |
This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a ...
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This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.
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| 56 | 2021-01-06 | swelling |
Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and li...
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Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and lips approx. at 1010. Benadryl 25mg by mouth administered. Patient continued to be monitored for additional 1hr. Benadryl improved symptoms, patient denied SOB and remained calm throughout. Swelling and tingling improved. Patient went back to work in hospital where received vaccine. Patient confident in monitoring return of symptoms while on site working. Patient reports list of allergies and has dealt with symptoms of allergic reactions before. This RN checked on patient after vaccine clinic and residual tingling remained but otherwise patient "felt good". Called patient at 1707 to follow up. Patient reports minor residual burning on lip otherwise other symptoms resolved. Continues to denies difficulty breathing, " I feel fine"
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| 56 | 2021-01-07 | lymph node swelling |
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG...
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HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
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| 56 | 2021-01-07 | peripheral swelling |
ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOUR...
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ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOURS.
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| 56 | 2021-01-09 | peripheral swelling |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-10 | anaphylactic reaction | Anaphylactic reaction |
| 56 | 2021-01-10 | lymph node swelling |
SWOLLEN & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING ...
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SWOLLEN & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING STARTED TO DECREASE BY SUNDAY AFTERNOON 1/8/21, SWELLING DOWN BY SUNDAY NIGHT 1/8/21
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| 56 | 2021-01-10 | peripheral swelling |
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic...
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10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
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| 56 | 2021-01-10 | swelling | Armpit is swollen |
| 56 | 2021-01-11 | swelling face |
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ...
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Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
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| 56 | 2021-01-13 | lymph node swelling, lymph node pain |
A week later I felt tenderness on my clavicle and discovered a swollen left supraclavicular lymph no...
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A week later I felt tenderness on my clavicle and discovered a swollen left supraclavicular lymph node still there and tender a week later
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| 56 | 2021-01-13 | swelling |
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT...
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PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
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| 56 | 2021-01-17 | lymph node swelling | swollen axillary lymph node under left arm |
| 56 | 2021-01-17 | swelling face, peripheral swelling |
I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after d...
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I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after doing that I felt light headed and out of breath. That continued for about 15-20 minutes. At 30 minutes after the injection my voice went hoarse. About an hour after I had a serve bullet like headache in one point in my head, I took Tylenol and lasted for about 5 hours. I started taking Benadryl (25mg), the headed improved, but when I woke up in the morning the next day I had all over swelling to the the point where I couldn't make a fist and had facial swelling . The facial swelling lasted for 5 days. My co worker took my vitals signs but everything was normal. For the next 5 days I had facial swelling that increased, hands got better. I continued to Benadryl . After the 5th day things finally started to get better. I did go back to have my second dose. I contacted my PCP but he was out of town .
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| 56 | 2021-01-18 | lymph node swelling |
Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and ten...
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Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine.
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| 56 | 2021-01-20 | lymph node swelling |
3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. S...
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3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. Shortly thereafter, started experiencing uncontrolled itching and my skin was bright red (flushed) from above pubic bone and up to top of my head. (nothing on lower extremities). No fever (98.1) and no visible rash. The itching became so uncontrollable, I took 25mg Benadryl and remained taking it every 4 hours until 1/21/21. A very fine, red rash appeared on 1/20/21 in the early morning. The rash was, mainly at my fatty areas, breasts, abdomen and hips, but the Benadryl helped to control the itching. The Benadryl did not take away the itching entirely. As of this morning, the rash has faded, but i'm still itching, mildly, in my abdomen and out edges of my breasts. I am going to try to stop the Benadryl this morning and see how I do. If not better, will go see my PCP.
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| 56 | 2021-01-20 | peripheral swelling |
Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a sp...
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Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient). A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine. She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown. Information on lot number/batch number was requested.
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| 56 | 2021-01-22 | swelling face |
swelling and blistering of skin around nose, right eye and right cheek. started 4 days after inject...
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swelling and blistering of skin around nose, right eye and right cheek. started 4 days after injection and worsened over 4 additional days before seeking medical treatment
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| 56 | 2021-01-22 | swelling |
Vaccine given at 7:30 am no symptoms until 7pm when temp started to climb, by 11pm temp was 104.5 ...
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Vaccine given at 7:30 am no symptoms until 7pm when temp started to climb, by 11pm temp was 104.5 despite Tylenol and ibuprophen. I also experienced joint pain and swelling over entire body. These were the same symptoms I had to an antibiotic years ago. The doctors referred to it as serum sickness.
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| 56 | 2021-01-23 | swelling |
fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area larg...
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fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area large where swelling was and migrating to feet and experiencing dizziness, heart is racing; gasping for air over phone but able to speak a complete sentences
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| 56 | 2021-01-24 | lymph node swelling |
Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and s...
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Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.
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| 56 | 2021-01-24 | lymph node swelling | Tachycardia pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration) |
| 56 | 2021-01-24 | swelling face |
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ...
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face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
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| 56 | 2021-01-25 | swollen extremities, lymph node swelling | Chills 1/23 Swollen lymph nodes in axillary of arm vaccine was administered |
| 56 | 2021-01-25 | swelling |
FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE,...
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FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE, EXTREME FATIGUE; FOGGINESS AND FEVERISH. SYMPTOMS BECAME MILDER AOUND 8PM ON 1/20 - TEHN OVERHEATED BUT CLEARERE. GRADUALLY GETTING BACK TO NORMAL TODAY 1/21. VERY DEHYDRATED. TOOK ADVIL. DRANK LOTS OF FLUIDS
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| 56 | 2021-01-27 | lymph node pain | Body aches, Tenderness under right arm - lymph node association, mid to lower back pain, |
| 56 | 2021-01-27 | lymph node pain |
Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg ...
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Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg relieved symptoms
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| 56 | 2021-01-27 | peripheral swelling |
Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and i...
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Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and ice packs did not improve area.
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| 56 | 2021-01-27 | swelling face |
Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report fro...
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Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
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| 56 | 2021-01-27 | swelling face | I had facial swelling where my eyes were almost swollen shut and violent diarrhea. |
| 56 | 2021-01-27 | swelling face |
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app...
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Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
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| 56 | 2021-01-28 | swelling face |
I feel ok during the observation period, after I left I felt pain on my face and numbness and tingli...
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I feel ok during the observation period, after I left I felt pain on my face and numbness and tingling. My face was swollen on the left side and my head on the left side hurt. I took some tylenol and went to bed. I had body aches. The body aches went away after the third day. Only my face hurt and it was kinda swollen. I called my doctor on the 5th day and he prescribed Gabapentin. The pain increased more and more each day.
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| 56 | 2021-01-29 | lymph node swelling | Headache fatigue chill fever nausea diarrhea lymph node swelling. Pain itchiness |
| 56 | 2021-01-29 | peripheral swelling, swelling face |
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa...
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Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
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| 56 | 2021-01-31 | swelling |
Pt reported swelling (now improving) of her cosmetic fillers. This has been reported with Moderna's ...
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Pt reported swelling (now improving) of her cosmetic fillers. This has been reported with Moderna's vaccine but not yet with Pfizer's to my knowledge.
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| 56 | 2021-02-01 | lymph node swelling |
Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shi...
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Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
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| 56 | 2021-02-01 | swelling |
left armpit and under arm became swollen and tender to the touch; left armpit and under arm became s...
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left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
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| 56 | 2021-02-02 | anaphylactic reaction | Anaphylaxis: abrupt throat swelling, shortness of breath, facial redness, GI distress |
| 56 | 2021-02-02 | lymph node swelling | Very enlarged lymph nodes in left axilla size of a grapefruit |
| 56 | 2021-02-04 | anaphylactic reaction |
patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl an...
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patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl and 2 doses of epi pen before being take by EMS to hospital
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| 56 | 2021-02-06 | swelling face, peripheral swelling, swelling |
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, sw...
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Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
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| 56 | 2021-02-07 | c-reactive protein increased |
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w...
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Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
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| 56 | 2021-02-07 | swollen extremities, lymph node pain |
Woke up Saturday morning with soreness and swelling in right armpit. Bothersome. Ended up taking ibu...
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Woke up Saturday morning with soreness and swelling in right armpit. Bothersome. Ended up taking ibuprofen and Tylenol in the afternoon. Seemed to relieve soreness. Today just a little sore. Swelling seems to have gone away.
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| 56 | 2021-02-07 | swelling |
complaint of increased swelling, pain and redness at injection site and circumference of left are 3 ...
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complaint of increased swelling, pain and redness at injection site and circumference of left are 3 days after second COVID injection right deltoid are measure 18.5inches Left deltoid measured 20 inches with hardness and redness
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| 56 | 2021-02-09 | anaphylactic reaction |
Patient had anaphylactic reaction to vaccine and was given #2 Benadryl and #2 doses of Epi-Pen befor...
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Patient had anaphylactic reaction to vaccine and was given #2 Benadryl and #2 doses of Epi-Pen before being taken to hospital by EMS.
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| 56 | 2021-02-09 | swelling |
Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; Thi...
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Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
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| 56 | 2021-02-10 | c-reactive protein increased |
Sob, low grade fever, bodyaches initially. Then persistent low grade fever, elevated liver GGT, ALT...
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Sob, low grade fever, bodyaches initially. Then persistent low grade fever, elevated liver GGT, ALT, AST, CRP nonhs, mild changes wbc diff, mild hepto and splenomegaly,
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| 56 | 2021-02-10 | lymph node swelling |
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating,...
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While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out. Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low. Called 911. Put oxygen on me, gave me Epipen, and checked sugar levels. Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up. Gave me water and orange juice. Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers. I was still trying to feel back to myself after a half hour to 45 minutes. My doctor says not to get 2nd dose in which I'm due on 2/21/2021. I started to feel back to myself around an hour later. I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing. No fever. I called my physician on 2-1-2021 to let her know what happened.
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| 56 | 2021-02-11 | anaphylactic reaction |
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1...
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Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
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| 56 | 2021-02-11 | peripheral swelling |
1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder...
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1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder to wrist. 1/28 L forearm and wrist began to swell and be very painful, complete loss of all wrist range of motion this continued thru Monday 2/8 This was so painful that I sought medical treatment from a MUSC health, Lanc MD on 2/5. He examined my wrist and sent me for an X-ray, X-ray was negetaive. Monday 2/8 the pain was subsiding from my wrist and began to start in my L shoulder. Wed 2/10 The pain had moved under my breast radiating from my L front around my back, severe along with shortness of breath. I went to ER for a complete work up including a CT to rule out a blood clot. All test negative all blood work normal. Except it did reveal that I had a UTI. I have never had a UTI in my life. I was started on a anitibiotic for the UTI. I still have the pain under my L breast. Unknown reason.
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| 56 | 2021-02-11 | white blood cell count increased |
I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I f...
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I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I felt fine and went to work. It was a normal day of rooming patients, I had lunch of yogurt and blueberries about 2 pm I started feeling very hot and "off". I went to the front of the office and checked my temp which was normal. As I walked down the hall to the back of the office I started feeling very nauseous, dizzy and my legs felt like jello. I sat down in my chair and got more dizzy so I put my head in my hands. The other MAs were asking me if I was ok but I couldn't think of the words and then I couldn't get the words out for about 10 seconds. When I did arouse again I was told I was slow to answer questions after
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| 56 | 2021-02-12 | oral herpes |
Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sournes...
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Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sourness. I also have a small area under the clavicle where there is a lump that also is extremely sensitive to touch. I developed a cold sore (herpes) on my chin. This is an area I've never had an outbreak on. This is still the case 4 days later.
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| 56 | 2021-02-14 | swelling |
Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side...
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Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-14 | swelling face |
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res...
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1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
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| 56 | 2021-02-14 | swelling face | Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst |
| 56 | 2021-02-15 | lymph node swelling |
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt...
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1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
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| 56 | 2021-02-19 | peripheral swelling |
The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I b...
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The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I began rubbing alcohol on the area. I hope this is common and will disappear soon.
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| 56 | 2021-02-21 | oral herpes, swelling face |
The doctor offer me some ointment for the cold sore but I am using something so I declined. Told me...
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The doctor offer me some ointment for the cold sore but I am using something so I declined. Told me to take NSAID for bump under my chin. I forgot to tell her about the pain in my left rib area.
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| 56 | 2021-02-22 | lymph node swelling | fairly severe, headache, lymph node swell |
| 56 | 2021-02-23 | swelling |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-24 | peripheral swelling |
Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger ...
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Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger to the joint as of 4pm on 2/24. On 2/25 in the morning the black and blue has extended beyond the knuckle toward the end of the finger but only about 1/4" beyond the knuckle. Right hand, middle finger, black and blue between the knuckle nearest the hand and the knuckle nearest the finger tip. No swelling. This was noticed about 9pm on 2/24. Covid Toes - possibly - red bumps on toes same toe, both feet, red. Toes next to pinky toe.
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| 56 | 2021-02-24 | peripheral swelling |
Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21...
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Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21 at 10:15 a.m. Approx 1500 - 1600 , the same day the injection site had "normal soreness, like a flu shot". On 12/22 woke up around 7 a.m. and couldn't move the affected arm due to pain. Reports it hurt to move her fingers. Temp was 99.5, maximum. The upper arm was swollen. On 12/23, temp is 97.6. Feels "normal soreness, like a flu shot
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| 56 | 2021-02-25 | lymph node swelling |
Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injectio...
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Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injection site. Overnite, intense HA noted that slightly subsided after 400mg ibuprofen, completely subsided by end of day 1/12/21. Body aches, malaise and a feeling that my left axillary lymph nodes were enlarged. All of these symptoms were at the worst in the middle of the night but all pretty much subsided by eve of 1/12/21.
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| 56 | 2021-02-25 | swelling |
Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light ...
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Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light red, slightly raised. Doesn't really bother me. No itching, burning or problems breathing. Took a Claritin and worked on 2/25. When I got home from work on2/25 showered and took a Benadryl. Rash is still here this morning. On my arms it is much lighter but still the same everywhere else.
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| 56 | 2021-02-28 | peripheral swelling |
I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelli...
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I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelling lasted for about a week and the spot faded after time.
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| 56 | 2021-02-28 | swelling |
Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status abo...
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Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status about 30 minutes after vaccine administration. Pt was able to calm down and described a slight alleviation in symptoms. Pt denied hx of anaphylaxis. Medics were dispatched to the location to transport. No medications given by health department or EMS on scene.
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| 56 | 2021-03-01 | oral herpes |
On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye ...
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On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye and growing pain in eye itself. Eye was watering and red and very painful. Symptoms persisted. On February 24, patient went to Urgent Care who found ulcerations on cornea and referred to ophthalmologist, Dr., who suspected herpes sores, perhaps due to an immune system reaction to the second Covid shot. Treated with eye drops (Moxifloxacin, 0.5% 4 times daily), and oral antiviral (Valaclyclovir HCL, 500 mg 2 tablets three times daily). Eye is MUCH improved, but the ulceration has not entirely disappeared. It is to be hoped that completing the Moxifloxacin and Valclyclavir regimen will completely clear the damage, but there is some concern that there may be permanent scarring. A fourth examination is scheduled for March 10.
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| 56 | 2021-03-01 | swelling |
Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for ...
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Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for about 48 hours. After 48 hours the rash started on top on both ankles. That lasted probably 8 days and didn't get better with cream. The muscle aches started in my neck and upper body and about 11days ago decided to settle in my knee (right). I though I maybe slipped or fell but didn't because of the pain. The pain is cross between a cramping muscle and shin pain. I've been walking with a limp. I got in yesterday with my PCP and sending me for an ultrasound to rule out a blood cot. He doesn't believe it is because it moves, I don't have any swelling or redness. I have just been really fatigue. I had BP done to make sure my Thyroid is ok and it is. The past 3 nights it has stopped waking me up at night. I've been doing epsilon salt baths, I can't put weight on it and still walk with a limp. I go for ultrasound tomorrow.
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| 56 | 2021-03-02 | lymph node swelling | Lymphadenopathy Very swollen, sore and red lymph nodes on the left side of the neck |
| 56 | 2021-03-02 | lymph node swelling |
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL...
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VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
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| 56 | 2021-03-02 | lymph node swelling |
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s...
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12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
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| 56 | 2021-03-04 | axillary mass |
Initially ( on the night of 2-26-2021 while taking a shower), I noticed a lump under my left armpit....
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Initially ( on the night of 2-26-2021 while taking a shower), I noticed a lump under my left armpit. It was slightly swollen and sore/painful to the touch...after about 3 to 4 days this subsided. On Monday ( March 1, 20201) until the present I have had intense pain at the nap on my neck -it is a stiffness and tightness. It is intermittent and can only be relieved with ibuprofen
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| 56 | 2021-03-06 | swelling face |
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after...
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Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn.. Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head. Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related to Covid Vaccine and to report it to VAERS. As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
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| 56 | 2021-03-07 | lymph node pain, lymph node swelling | EXTREME SWELLING OF LEFT LYMPH NODE WITH PAIN. |
| 56 | 2021-03-07 | lymph node swelling, lymph node pain | Swollen tender lymph nodes on back of neck |
| 56 | 2021-03-07 | lymph node swelling |
sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a co...
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sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a contactable physician, reporting for herself. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), intramuscularly at the right deltoid on 04Feb2021 12:30 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no other medications received within 2 weeks of vaccination. There were no known drug allergies. The patient previously received fist dose of BNT162B2 (lot number: EL3246), intramuscularly at the right arm on 14Jan2021 14:30 for COVID-19 immunization. On 05Feb2021 22:00, the patient developed sharp, unremitting right axillary pain and lymphadenopathy. She had a normal mammogram earlier this year and no injuries or other reasons to suspect this pain and swelling was due to anything other than a reaction to the 2nd COVID-19 vax. The patient was not worried nor upset, just wanted to pass along this information. No treatment was received. The outcome of the events was not recovered.
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| 56 | 2021-03-07 | lymph node swelling | Swollen lymph nodes in the right side of neck |
| 56 | 2021-03-08 | lymph node swelling |
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm...
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On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
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| 56 | 2021-03-09 | lymph node swelling |
Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headac...
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Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headache; Mild tiredness; chills; low fever; This is a spontaneous report from a contactable Consumer. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (Lot Number: EW 5318) via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3248) on 13Jan2021 without expected adverse event (arm pain and tiredness). The patient had lymphadenopathy in the glands of the armpit were the first and second shot were given on 05Feb2021. Strong headache (not improving with Acetaminophen 500 mg on 04Feb2021, Mild tiredness, chills and low fever on 03Feb2021. The patient started Tylenol for the common symptoms expected after the shot that day (as recommended by the vaccination center). Tiredness started that day. The strong headache started late afternoon of 04Feb2021 (less than 24 hrs. from reporting). On 05Feb2021 around 8:00 the armpit swollen. There was not a sudden but a progression of symptoms. The patient didn't report the events aware that are common from vaccination, and reported (1 hour, 25 minutes) about the armpit swollen. The patient stated that the tiredness was indicated as a common effect so not report it Tylenol was recommended. The strong headache started late on 04Feb2021 and the armpit swollen the day after 05Feb2021 (Early in the morning). The patient took rest on the weekend and changed from Tylenol to Naproxen. Headache and swollen armpit (left side where the shot was given) disappeared. Feeling well since yesterday (currently without medication). The outcome of the event strong headache and Lymphadenopathy in the glands of the armpit were the first and second shot were given was recovered and outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-03-10 | lymph node swelling, swelling face |
03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face s...
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03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face swelling on the left side and also swollen lymph nodes, symptoms still continue 03/11/2021.
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| 56 | 2021-03-10 | lymph node swelling, swelling |
initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on ...
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initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on 14 days now. Some improvement but continue to feel somewhat breathless at times, extreme fatigue (abnormal for me), decreased appetite, muscle aches (severe at times), tightness in my jaw on left side with noticeable jaw clicking that I have never had, and on day 3 woke with severe, noticeable swelling in my left axilla (egg shaped and protruding) and my left neck/jaw -- also seems to be in the lymph node area. Underarm swelling improved but still have a sense of tightness in my neck and jaw.
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| 56 | 2021-03-10 | lymph node swelling | Swollen supra clavicle node |
| 56 | 2021-03-10 | lymph node swelling | Fatigue Headache Muscle pain Chills Joint pain Low fever Swollen left arm lymph nodes |
| 56 | 2021-03-11 | lymph node swelling, lymph node pain |
Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it....
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Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it. Later that same day it had gone up to 102.4. I had no appetite and extreme fatigue. Took Tylenol which lowered the fever. Day 3 my temperature stayed at 102.4 and I had painful, swollen glands along my left clavicle, as well as fatigue. Also, the injection site became hot and swollen. Day 4, my temperature has gone down but I have a terrible headache, swollen clavicle glands and a chain of swollen nodes (?) from the base of my skull down the back of my neck on the right side. My left arm is still hot and swollen at the injection site. I've had to miss two days of work.
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| 56 | 2021-03-11 | swelling |
Patient presents with generalized swelling/lump left clavicular area which began after receiving sec...
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Patient presents with generalized swelling/lump left clavicular area which began after receiving second dose of covid vaccine and persistent at 6 weeks post second dose
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| 56 | 2021-03-12 | swollen extremities |
I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable ...
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I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable in my left armpit since Friday 3/12/21 noon, but I only realized it was swollen when I went to take a shower around 8:00 pm. I'm feeling it swollen, burning and mild pain.
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| 56 | 2021-03-12 | peripheral swelling |
About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomit...
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About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomited probably around 7-8 times (maybe more), and the last 2 times there was nothing left in my stomach to come up and I was just heaving. I also had moderately severe lower abdomen cramps (just above my pelvic bone). It felt like my insides were twisting at times, and the pain was constant cramping with moments of pretty severe twisting doubling over pain. I had chills just before the vomiting started, and felt like I had a slight fever, but because of the constant nausea/vomiting I did not take my temperature (all I have is an oral thermometer). To get the pain to stop, I had to lay down on a bed and put pressure on my stomach sides to ease the cramping. I tried taking Pepto-bismol to stop the nausea and vomiting, but immediately vomited that up too. The vomiting finally stopped after 2 times of dry heaving and nothing left to come up. The severe lower abdomen stomach cramping calmed down around 1 or 2 am. Today I feel weak, my right arm is very sore and slightly swollen, and as of the time of this report at 2:30pm I have only eaten some saltine crackers today. My stomach still feels weak, even though the nausea, cramping, and vomiting have gone away now.
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| 56 | 2021-03-13 | lymph node swelling, peripheral swelling | Swelling in arm on day 1 and 2, headache for two days, Lymph node swollen Day 3. |
| 56 | 2021-03-13 | lymph node swelling | Left Under arm swollen and pain, some pain in arm |
| 56 | 2021-03-14 | lymph node swelling | Swollen lymph nodes under arm, small red, dry area on arm, pimple style sores |
| 56 | 2021-03-15 | lymph node swelling, lymph node pain | pain in R arm/bicep swollen lymph nodes over right clavicle, with redness and pain on palpation |
| 56 | 2021-03-15 | lymph node swelling |
I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consume...
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I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient reported that first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# EL9264), via unspecified route of administration on 04Feb2021 13:45 at single dose in the left arm for covid-19 immunization. Medical history included hypertension. Concomitant medications included Lycortin, Norvasc, Carvedilol, Aspirin, Doxycycline. The patient reported as, I had a swollen lymp node in my left armpit on 08Feb2021. Outcome of the event was not recovered.
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| 56 | 2021-03-15 | peripheral swelling, swelling face |
severe swelling of face; including eyes, under eyes, checks. Swollen hands and swollen feet. Went ...
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severe swelling of face; including eyes, under eyes, checks. Swollen hands and swollen feet. Went to Hospital Emergency Room. Given IV steriod and benedryl shots. Put on steriod pack and follow up with PCP who recommends I do not get the 2nd shot due to adverse reaction
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| 56 | 2021-03-15 | peripheral swelling |
Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progresse...
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Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progressed to entire body after about an hour. Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued. Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
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| 56 | 2021-03-15 | peripheral swelling |
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximate...
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2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day. 3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
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| 56 | 2021-03-17 | lymph node swelling, lymph node pain, swelling |
Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after ...
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Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after shot and continued on and off until 60 hours after the shot. All over body aches and skin sensitivity began 11 hours after the shot and continued for 36 hours and then resolved. Swollen lymph node at left armpit began 11 hours after the shot and was/is uncomfortable and at times painful. Initially the swelling was very pronounced and interfered with arm movement. The swelling has diminished a bit now (75 hours after the shot), but there is still some swelling and occasional pain.
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| 56 | 2021-03-18 | lymph node swelling |
Large (size of orange) swollen lymph nodes under left arm. Used warm compresses and Advil Still co...
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Large (size of orange) swollen lymph nodes under left arm. Used warm compresses and Advil Still continuing as of 03/19/2021 but swelling is lessening.
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| 56 | 2021-03-18 | peripheral swelling |
"PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at v...
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"PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at vaccination site. Due to Pt's hx of moderate allergice reaction to IV iodine during a medical procedure "years ago", pt placed on 30-minute ovservation period. Approx 10 minutes into observation, pt notified staff that she felt some itching on her right arm in crease of elbow. Pt. also saw what she described as bumps or hives the size of a half dollar. Pt moved to private restroom and redness and swelling found progressing behind pt's right knee 5 minutes later. IM Benedryl administered to patient and transport medic unit called. Full report given to transport crew. Pt transported to ED.
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| 56 | 2021-03-18 | swelling face | Swollen lip and chin about 12 hours after vaccine; doctor has advised to try Tylenol PM |
| 56 | 2021-03-19 | lymph node swelling | Headaches on day 6,7,8 Swollen lymph node on neck ...same side as the injection And still present |
| 56 | 2021-03-23 | anaphylactic reaction |
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s...
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Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
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| 56 | 2021-03-23 | lymph node swelling |
Swelling of lymph node under the injection arm. Swelled to size of golf ball and lasted one week. ...
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Swelling of lymph node under the injection arm. Swelled to size of golf ball and lasted one week. Fatigue lasted 2 days.
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| 56 | 2021-03-23 | peripheral swelling |
Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still o...
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Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still occurring.
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| 56 | 2021-03-24 | lymph node swelling |
After my first dose Pfizer vaccine, I developed enlarged lymph nodes found in a calcium scan. I unde...
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After my first dose Pfizer vaccine, I developed enlarged lymph nodes found in a calcium scan. I underwent CT scan, mammogram and ultrasound of the axilla. They thought it could be breast cancer or lymphoma. Today my lymph noes are still present.
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| 56 | 2021-03-24 | lymph node swelling |
Pt received 1st dose COVID vaccine on 2/24/21. When she returned for 2nd dose on 3/17/21, reported t...
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Pt received 1st dose COVID vaccine on 2/24/21. When she returned for 2nd dose on 3/17/21, reported that she had "fatigue for 3 days afterward, but also worked long hours those 3 days". Reported "swollen glands in throat and neck" on the 3rd day "that lasted about 8 hours". Reported "she could breathe fine through nose" and denied any other difficulties breathing. Stated her grandson "said she didn't sound right when she was sleeping" but pt denied any difficulty breathing or sleeping. Denied any rash, itching, or other s/s allergic ran/anaphylaxis. Did not seek medical care.
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| 56 | 2021-03-25 | swelling face |
Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore...
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Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore throat
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| 56 | 2021-03-26 | lymph node swelling | Fever, chills, shaking, body aches, and underarm lymph nodes swelled more |
| 56 | 2021-03-27 | peripheral swelling |
Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving...
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Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving vaccination (3/21/21) stopped (3/23/2021)
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| 56 | 2021-03-27 | swelling face |
Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck....
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Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck. I took half of a Zytec antihistamine, one Advil and drank extra water. Applied an ice pack. Stiff neck stopped at 36 hours. Swollen tongue stopped at 48 hours. Left cheek swelling went down by 50 % at 72 hours.
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| 56 | 2021-03-27 | swelling, peripheral swelling |
Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swe...
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Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swelling, redness. Extremity swelling. Coughing and chest pain. Extreme fatigue. Today, the pain is so bad I am on the couch. Doctors visit tomorrow
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| 56 | 2021-03-28 | lymph node pain, lymph node swelling |
24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and ...
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24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and chills, 75hrs from vaccine swollen axillary lymph nodes (same arm as vaccine) >10cm in diameter, very painful with pressure on the inside of the left arm extending to the elbow.
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| 56 | 2021-03-28 | swelling |
Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then droppe...
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Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then dropped to 97.3...symptoms severe missed 5 days of work...brain felt like it was swollen, also felt dizzy...started feeling like able to do daily routine on Saturday 3/27...but still weak and tire easily. Also, since this..my poop looks yellowish and floats every time. To be honest I am afraid of getting the 2nd vaccine.
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| 56 | 2021-03-28 | swelling |
3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand....
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3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand. Same side as injection. I started having tingling and itchy gums itchy throat and itchy ears. My throat swelled up on both sides. All of the above in mild form. I was still sitting in my car in the parking lot & remained there for an additional 30 minutes to make sure it did not get worse. I subsequently ate lunch and continued with my day. Around 9:45pm I went to bed and found that when I would lie down I experienced increased difficulty in swallowing as neck was still swollen both sides under ears and around jaw line. At 10:00pm I took 1 single 25mg Benadryl tablet. Swelling subsided noticeably within 20 minutes. The following day (3/27/2021) much improved with only slight swelling on the left side of my throat under my left ear and along jaw line. Right arm sore from shoulder down to my wrist. By the end of the day my arm was no longer sore. Left side of my throat was still slightly swollen. At bedtime I took 1/2 of a 25 mg Benadryl tablet. Felt fine on Sunday however i still feel as if i have slight swelling
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| 56 | 2021-03-29 | lymph node swelling | Headache, tiredness, lump under my right armpit |
| 56 | 2021-03-29 | lymph node swelling |
Rash on face, still here after 3 weeks; day after was tired, nauseated, muscle and joint paint, swol...
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Rash on face, still here after 3 weeks; day after was tired, nauseated, muscle and joint paint, swollen lymph nodes, that has resolved itself
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| 56 | 2021-03-29 | swelling face |
two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, diz...
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two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, dizzy, headache, muscles and joint pain every where like I had the flu, chills, nausea, face and throat swollen and knots on throat, my mouth had sores on my gums, I had a cough and had to take medication for that, sore throat, my fever was up and down.
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| 56 | 2021-03-29 | swelling face |
Patient had swelling of her face five days after the vaccine and fluid accumulated under her eyes. ...
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Patient had swelling of her face five days after the vaccine and fluid accumulated under her eyes. This lasted for 3 days and she took Benadryl to make the symptoms bearable.
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| 56 | 2021-03-29 | swelling face |
I had the Pfizer vaccine for Covid. My neck started to break out in hives on my neck around 45 min ...
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I had the Pfizer vaccine for Covid. My neck started to break out in hives on my neck around 45 min after the shot. Then my face started to turn red and swell up. I then started to have more urticaria hives on my face. I went to the Urgency room and they gave me a epinephrine shot, steriods, Pepcid and Benadryl. The hives and redness started to disappear right after the shot.
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| 56 | 2021-03-30 | lymph node swelling |
The side effect with the second dose of Pfizer-Biotech was swollen lymph nodes (lymphadenopathy) on ...
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The side effect with the second dose of Pfizer-Biotech was swollen lymph nodes (lymphadenopathy) on the left armpit. The side effect began on March 27, 2021, around 2:00 am. As of March 31, 2021, there are still side effects but not as bad as March 27th.
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| 56 | 2021-03-30 | oral herpes |
Head ache every day starting the day after, 3-day later, rash in throat (cold sores or something sim...
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Head ache every day starting the day after, 3-day later, rash in throat (cold sores or something similar on roof of mouth), rash under right arm and rash on lower left-back.
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| 56 | 2021-03-30 | peripheral swelling, lymph node swelling |
Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swel...
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Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swelling of right arm to hand, fluid in and around arm pit. Next day, fever 102.7 headache, joint pain, muscle pain, and arm still affected. Day 2, still fluid in arm pit area and headache. Evening of day 2 ran fever of 102.6 with pain on right side of ne k and headache. Day 3 headache and fluid in and around arm pit has subsided a bit.
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| 56 | 2021-03-30 | swelling face |
Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednis...
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Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednisone 10 day pack
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| 56 | 2021-03-30 | swelling face | There was an allergic reaction that caused itchiness all over the body as well as facial swelling. |
| 56 | 2021-03-31 | swelling |
angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a cont...
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angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-03-31 | lymph node swelling |
Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin...
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Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin,
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| 56 | 2021-03-31 | peripheral swelling |
Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painfu...
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Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painful. hand swelling; chills and low grade fever.
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| 56 | 2021-04-02 | lymph node pain, lymph node swelling | Swollen underarm. Very painful |
| 56 | 2021-04-03 | swelling | Swelling, pain and redness that continues to spread 3 days after injection. |
| 56 | 2021-04-04 | lymph node swelling, peripheral swelling |
swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post m...
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swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post menopausal bleeding/spotting/cramping, increased pain in healing right torn rotator cuff
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| 56 | 2021-04-08 | swelling, swelling face |
Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling fac...
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Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration on 17Mar2021 06:00 PM as single dose in right arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included idiopathic angioedema and no chronic health conditions. Patient had allergies to medications, food, or other products included Zithromax - anaphylactic, several other antibiotic - rash, hornet and wasp sting allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 at 10:00 AM, the patient experienced angioedema - swelling face, eyes, lips and throat which occurred 16 hours after injection. Event resolved with use of Benadryl. Prior history of angioedema. Since symptoms resolved with Benadryl, I did not seek further medical care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events were recovered in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-04-12 | anaphylactic reaction |
allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closi...
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allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.
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| 56 | 2021-04-16 | peripheral swelling, lymph node swelling |
I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my lef...
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I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my left knee on March 13th. (I had my first vaccine shot in my left arm on March 11th. ) I thought that I would let it heal. My second shot was April 1st and my left leg became very painful after that. I went to the Doc. for a knee sprain, was sent to Orthopedic. I received an X-ray and an MRI. There is tricompartmental osteoarthritis, with 2 degenerative meniscus tears. It occurred to me today that my knee joint may be reacting to the vaccination. I did have swollen lymph nodes on my left side in neck and under my arm after the second shot. My knee has had arthritis and possibly the degenerative meniscus tears but it has never become swollen and inflamed. The swelling and pain has persisted for over 2 weeks now. I?m not sure if it is related but I thought that I should share this with you. If there is anything that you can help with, please do. I have been so very grateful for the vaccination. Thank you!
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| 56 | 2021-04-20 | lymph node swelling |
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L...
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Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
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| 56 | 2021-04-22 | lymph node swelling |
I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had ...
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I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had been building over the past mo. I procrastinated going to the ER, because I wanted my 2nd dose b4 going, which was yesterday. I had exams, pelvic, ultrasounds, Cat scans, labs, etc & they found nothing. I can barely walk without doubling over. 4 wks ago I had an L-5 block & trigger point injections with steroids, due to inflamed nerve roots, & inflamed L thigh. 1 wk later, I had my 1st shot, L arm. Within days my abdomen began hurting mildly, but I thot it'd subside. It never occurred to me that it could be related to the vaccine. 2 wks later, it was unbearable & I thot it an ovarian cyst. I waited for my 2nd shot appt, b4 going to ER, in case I was hospitalized. I didn't want to ruin my 2nd dose, as I have lung issues. ER Dr said, I had "undetermined inguinal pain". Then, I found a study about women, hormonal changes & the vaccine. I saw that lymph nodes can get inflamed after a vaccine. Now, I think I had a vulnerable area on my L side, then rec'd steroids L side, which lowered my immune system. Next, I rec'd my 1st shot L side, & my "inguinal lymph node" on L side became inflamed. It got progressively worse, & now my 2nd dose was yesterday, also on my L side, & has aggrivated it even more. Tomorrow I see my pcp. It feels exactly like my ovary's swollen, & the inguinal lymph node's located right in the same place, so after all tests have been negative, I suspect a connection & I'll discuss with pcp for more testing & treatment.
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| 56 | 2021-04-23 | lymph node swelling |
She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better ...
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She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better the following day. She eventually succumbed and passed away.
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| 56 | 2021-04-27 | swelling |
Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). T...
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Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021330573 same patient, vaccine different dose
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| 56 | 2021-04-27 | peripheral swelling, swelling face, white blood cell count increased |
Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in ...
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Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in the spring. They typically occur along with seasonal allergies and she thinks the hives are unrelated to current rash. She went ahead and had the 1st Pfizer vaccine on 3/3. She developed a new circular rash at the injection site on the left arm and new rash over the left side of her back described as ?on fire?. she was seen for a telemedicine clinic visit diagnosed with possible shingles and was prescribed treatment. Did not improve significantly. She went ahead and had the second Pfizer jab on 3/24. She developed extreme tenderness at injection site. the rash that was on her back got much worse and spread. The rash occurs any place she scratches, has blood drawn or gets a band-aid placement. After that second shot she also noticed that her hip joints feel ?weak and unhinged". . Has also had similar symptoms of weakness in bilateral shoulders. Feels like her leg muscles are weak (points specifically to quadriceps). She has trouble repositioning herself and doing normal activities that she had been doing without difficulty just a few weeks ago. Her RN notes that she can get out of bed and walk to bathroom but is unsteady and shuffles. Has also noticed facial and periorbital swelling with purple discoloration and darkness around eyes. Had a faint pink rash extending from eyelids up over brows that has now decreased. Feels her legs are puffy and swollen.
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| 56 | 2021-04-29 | anaphylactic reaction | Anaphylaxis |
| 56 | 2021-04-30 | swelling face |
Left side face swelling; This is a spontaneous report from a contactable consumer reported for herse...
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Left side face swelling; This is a spontaneous report from a contactable consumer reported for herself. This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm (reported as "left shoulder") on 07Apr2021 13:00 as a single dose for covid-19 immunisation. Medical history included asthma diagnosed as a child. The patient stated it's not ongoing, it's more during seasonal allergies. She took Singulair to help. Concomitant medications were unknown. The patient had Pfizer covid19 vaccine on Wednesday 07Apr2021 and left side face swelling yesterday on 08Apr2021. It's on the left side of the face. It started around the eye and currently she can feel it running down the side of the face. Left side face swelling was reported as worsened. The patient asked if she would be okay to get the second vaccine. She stated she was not in pain, but was concerned that she won't be able to get the second vaccine. She had not treated the swelling yet, and was not sure if she should see her doctor. She was scheduled for the second dose of the vaccine. The patient had no prior Vaccinations (within 4 weeks). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 56 | 2021-05-10 | anaphylactic reaction |
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache...
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anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
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| 57 | 2021-01-04 | peripheral swelling |
some swelling on the underside of this same arm; This is a spontaneous report from a contactable con...
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some swelling on the underside of this same arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) at single dose via an unknown route in her right arm on 20Dec2020 09:50 for Covid-19 immunization. Medical history and concomitant drug were not provided. Past drug history included a reaction to an antibiotic, cefadroxil (DURICEF). Patient received her initial Covid-19 vaccine in her right arm and noted some swelling on the underside of this same arm on 21Dec2020. She wanted to know if this might be associated with the vaccine. Patient stated she had that got the vaccine on 20Dec2020 at 9:50AM in the right arm, that on Monday the next day, 21Dec2020, she got this swelling under her arm. Patient stated did not know if it had anything to do with that, wanted to know if it is a side effect. Patient stated that the swelling started on Monday the next day, 21Dec2020. Patient stated the swelling has improved but she was going to the doctor to make sure everything was okay. Patient stated that years ago she had a reaction to an antibiotic, cefadroxil. She asked her doctor if she should get the shot because of that and they told her she should, states this happened like 25 years ago as of 30Dec2020, no details known. Outcome of the event was resolving.
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| 57 | 2021-01-05 | lymph node swelling | Lymphadenopathy |
| 57 | 2021-01-07 | peripheral swelling |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-10 | anaphylactic reaction, peripheral swelling |
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled...
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Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-10 | lymph node swelling | headache swollen glands in throat injection site soreness |
| 57 | 2021-01-10 | lymph node swelling | Body Aches, headache, Swollen Lymph nodes |
| 57 | 2021-01-10 | lymph node swelling | left sided axillary and cervical lymphadenopathy |
| 57 | 2021-01-10 | lymph node swelling |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-10 | lymph node swelling | Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose |
| 57 | 2021-01-10 | peripheral swelling |
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C...
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HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
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| 57 | 2021-01-10 | swelling |
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if ma...
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Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist. Now pain when holding a mug or glass but not other movement. Still swollen at time of report 1/11/2021 but much less painful. On the 28th and 29th of December I took 200mg ibuprofen, 3 or 4 doses over the two days, with some benefit.
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| 57 | 2021-01-11 | c-reactive protein increased |
Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID va...
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Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.
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| 57 | 2021-01-12 | swollen extremities |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-13 | lymph node swelling | Swollen Lymph node in arm pit that has not subsided as of today 1/14/2021 |
| 57 | 2021-01-14 | anaphylactic reaction |
difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness...
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difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-14 | peripheral swelling |
Mild reaction; Left arm swelling; This is a spontaneous report from a contactable nurse. A 57-year-...
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Mild reaction; Left arm swelling; This is a spontaneous report from a contactable nurse. A 57-year-old female nurse reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142, Expiry Date 31Mar2021), intramuscular into the left arm on at single dose on 05Jan2021 for COVID-19 immunization. The patient's medical history was none and the patient did not receive other products. The patient reported that when I received the vaccination she patient experienced mild reaction left arm swelling. She did not had it before this vaccine. At the time of reporting it is gone down now. She did not take any treatment.
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| 57 | 2021-01-14 | peripheral swelling |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-16 | peripheral swelling |
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0...
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I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
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| 57 | 2021-01-17 | lymph node swelling | Right axillary lymphadenopathy/pain one day after 2nd vaccination x3 days. Resolved. |
| 57 | 2021-01-17 | oral herpes | Fever, Chills, Headache, Body aches, cold sore after 48 hours |
| 57 | 2021-01-18 | lymph node pain, lymph node swelling |
SWOLLEN, PAINFUL LYMPH NODES, UNDER CHIN, OVER COLLAR BONE AND AT BASE OF SCULL BEHIND LEFT EAR . ...
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SWOLLEN, PAINFUL LYMPH NODES, UNDER CHIN, OVER COLLAR BONE AND AT BASE OF SCULL BEHIND LEFT EAR . ALL ON LEFT SIDE. NODE OVER COLLAR BONE IS VERY PAINFUL TO TOUCH AN D VERY SWOLLEN
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| 57 | 2021-01-20 | swelling face |
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; ...
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At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS). The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
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| 57 | 2021-01-21 | lymph node swelling, anaphylactic reaction |
Patient had vaccine at 1430. At 1600, patient returned to vaccine clinic complaining of swollen glan...
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Patient had vaccine at 1430. At 1600, patient returned to vaccine clinic complaining of swollen glands and feeling of potential throat swelling, asking for benadryl. Patient states she has had an anaphylactic reaction in the past, but never to a vaccine or medication. Vital signs taken - BP 166/90, pulse 103, SpO2 100%. Patient monitored for few minutes and continued to feel additional tightness in her throat. Crisis nurse called and patient transported to ED for further evaluation. diphenhydramine 25mg PO given in ED at 1838. Pt reports self taking ibuporfen 600mg at 1535. She has had anaphylaxis in the past 5 years ago to food (treated with solumedrol and benadryl) and once walking thorugh the park>25 years ago an
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| 57 | 2021-01-23 | swelling, lymph node swelling |
Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a...
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Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a few hours lympnodes in my neck, behind my ear and on my collar bone were all swollen and painful. On Wednesday 01/20/2021 I developed hives on my scalp, in my left ear, and on and around all swollen lymph nodes. I left work on 1/20, still couldn't go to work 1/21 on 1/22 I saw Dr. Who have me a shot of Kenalog and some triamcinolone cream for hives. I tried to work, but only lasted 4 hrs and went home. It is now one week since vaccine number two and on top of still raw spreading hives, and swollen glands , I now have a sharp pain constantly shooting through my left temple which is relentless. I am miserable.
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| 57 | 2021-01-24 | lymph node pain |
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ...
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Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-24 | lymph node swelling | Elevation of the lymph node in the left armpit with tenderness |
| 57 | 2021-01-24 | lymph node swelling |
Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time ...
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Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time that had passed since she received the vaccine. She was seen in urgent care. Notes from that encounter states, "...presents for swollen lymph nodes x 3 days, received second covid vaccine on 1/13/21 and had dental procedure that day, just finished bactrim. Physical exam as above; non-toxic, well-appearing, afebrile in NAD. Cervical adenopathy present along with L>R inguinal lymphadenopathy, bilateral inguinal lymphadenopathy. She has received the second covid vaccination and this seems consistent with post vaccination adenopathy. No dental abscess/infection or evidence of tonsillar exudates to suggest strep pharyngitis. Upon discussion with ED staff physician, she reports she has been working excessively and feels fatigued. She was encouraged to take the day off of work today and was given a work note. Encouraged PCP follow up to ensure improvement in symptoms. The ER research team was contacted and will chart review and follow up regarding adenopathy after second covid vaccine. Reviewed return to ED precautions. In ED labs were drawn, EE was given Ibuprofen and advised to follow up with PCP is symptoms persist or worsen.
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| 57 | 2021-01-24 | lymph node swelling | Supraclavicular lymphadenopathy |
| 57 | 2021-01-24 | lymph node swelling |
I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most...
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I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most of the day, and at 730 pm I noticed a large, moveable, painful swollen lymph node above my left clavicle .
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| 57 | 2021-01-25 | peripheral swelling |
Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no ...
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Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no pain. Tues. 1/26 had 30 seconds where it was hard to breathe, "like gasping for air".
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| 57 | 2021-01-27 | lymph node swelling |
malaise, generalized myalgias, low grade temp (99.2) noted 1/24/21, lasting 12 hrs. Left sided cerv...
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malaise, generalized myalgias, low grade temp (99.2) noted 1/24/21, lasting 12 hrs. Left sided cervical adenopathy noted 1/25/21, persisting.
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| 57 | 2021-01-27 | lymph node swelling |
Received vaccine on Friday morning 1/8/21. On Sunday evening 1/10/21 noticed a lump on left collarb...
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Received vaccine on Friday morning 1/8/21. On Sunday evening 1/10/21 noticed a lump on left collarbone area. Saw CRNP on the afternoon of 1/11/21. She examined and felt it was an enlarged lymph node. Order ultrasound which was performed 1/18/21 and bloodwork. Awaiting results from all testing. Lump is still present at this time.
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| 57 | 2021-01-28 | lymph node swelling | Neck pain/tenderness, Shoulder tenderness moving to right side, lymphadenopathy |
| 57 | 2021-01-28 | swollen extremities |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | peripheral swelling |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-02 | lymph node swelling, oral herpes |
Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the f...
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Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep Jan 31 - ear pain, headache, slight aches, trouble falling asleep Feb 1 - feeling better, some ear pain, trouble falling asleep
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| 57 | 2021-02-03 | swelling face |
Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130...
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Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy. Took Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief. 6 hours later, awoke with itchy throat and face and took Benadryl 25mg with relief. Next morning, 2/1/2021: 8 am ate my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief. 11:30 ate pretzels and face started itching `15 minutes later. Everything I ate that day caused me to itch 15 min afterwards just like when I would have food reactions when first diagnosed with Alpha Gal and my IGE histamine levels with 3x normal. I increased my Allegra 180mg to 3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours. 48hours after vaccine I was able to decrease Allegra 180mg to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards. My allergist felt the 2nd vaccine may have caused an inflammatory response and flared up my alpha gal symptoms.
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| 57 | 2021-02-03 | swelling |
Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 pos...
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Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 post vaccination. Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
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| 57 | 2021-02-05 | lymph node pain |
Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, ...
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Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, all over pain ,achness, headache, fatigue and all over chills. Took tylonal and went to bed for 14 hours. Still experiencing pain, slight headache and achness all over. Fever and nausea gone.
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| 57 | 2021-02-05 | lymph node swelling | Swollen and painful lymph nodes in armpit of left arm |
| 57 | 2021-02-05 | peripheral swelling | RUE 4 in x 4 in large, painful, raised area that has decreased in size and pain but still remains. |
| 57 | 2021-02-10 | swelling face |
Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left ...
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Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-11 | lymph node swelling |
STARTED HAVING AXILLARY PAIN NEXT DAY AND FELT SOME NODE SWELLING BUT IT SLOWLY WENT AWAY. THEN I HA...
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STARTED HAVING AXILLARY PAIN NEXT DAY AND FELT SOME NODE SWELLING BUT IT SLOWLY WENT AWAY. THEN I HAD THE SECOND DOSE IN THE SAME ARM AND STARTED PAIN ANS SOME SWELLING BACK TO THE SAME LEFT AXILLA.I HAD BODY ACHES AND TIRED NESS THE NEXT DAY, I TOOK TYLENOL ES 2 TABS.
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| 57 | 2021-02-11 | swelling, lymph node swelling | Swelling, pain, knot in lymph node in underarm of shot arm |
| 57 | 2021-02-13 | lymph node swelling | Fever, swollen lymph glands, sore throat, fatigue, nausea, vomiting |
| 57 | 2021-02-13 | lymph node swelling | Swollen Gland Body Aches headache |
| 57 | 2021-02-14 | peripheral swelling |
On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL...
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On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL shirt, wears M. Had red splotches on it, pain and swelling for 7 days after the vaccine. There was red splotches on the arm, but now 2/15/21 there are now white dots where the red lines used to be. Did not take anything for it, as she did not know what to do. She called her doctor, but they did not address the problem. When she went to work on 1/12/21 had another lady that is a corporate nurse and told her that it was bad. Arm is still hurting, and is in the process of recovering. If she pushes on the location of the vaccine it does hurt. She has not and will not take the 2nd vaccine.
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| 57 | 2021-02-15 | lymph node swelling | Swollen painful lymph node under left arm |
| 57 | 2021-02-16 | lymph node swelling |
Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right a...
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Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right arm.
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| 57 | 2021-02-17 | peripheral swelling, swelling, swelling face |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-19 | swollen extremities |
Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle s...
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Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle strength of entire arm. Inability to move arm. Symptoms continuously got worse for next 5 days. Pain started to decrease on February 6 and symptoms gradually improved over the following week.
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| 57 | 2021-02-19 | swelling face |
Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (...
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Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (right upper and left lower) seemed like fluid filled pockets but later lips were completely swollen, the next day my chin became very hard and swollen, no tongue edema noted, no other swelling of face noted. It is now 6 weeks later and I continue to have lip and chin edema. Have been on high dose steroids but rebound within 48 hours. I am currently on antihistamine regimen of Allegra, Singulair, Pepcid and Atarax x one week with continued swelling, although it does lessen throughout the day but every morning I am very swollen despite medication regimen.
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| 57 | 2021-02-20 | lymph node pain |
Sore tenderness under left armpit and left side of neck. General tiredness and lethargic, mild heada...
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Sore tenderness under left armpit and left side of neck. General tiredness and lethargic, mild headache.
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| 57 | 2021-02-20 | sepsis |
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness...
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She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
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| 57 | 2021-02-23 | lymph node swelling |
Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, an...
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Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, and had swelling under arm, that is still there, though it has gone done. She satted it feels like it spread to her breast. She also stated she had a twitching on the side of her mouth that lasted a second. She denies, fever, SOB, chest pain, rash, or any other symptoms. She stated she is taking Tylenol every 6 hours which is helping. RN reviewed red flags to call 911. RN reviewed would folllow up tomorrow with her.
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| 57 | 2021-02-23 | peripheral swelling |
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ...
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Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
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| 57 | 2021-02-23 | swelling | Weakness to left leg. Swelling to left armpit and left breast. |
| 57 | 2021-02-24 | peripheral swelling |
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s...
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General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
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| 57 | 2021-03-01 | lymph node swelling | injection site pain, injection site swelling, muscle pain, chills, swollen lymph nodes, nausea |
| 57 | 2021-03-02 | lymph node swelling |
high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of he...
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high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of heavy; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on the left arm on 28Jan2021 at a single dose for Covid-19 immunization. The patient medical history included that she was diabetic, and she have had COVID and she have been in long term for COVID from Jul2020 and unknown if ongoing. Concomitant medication included metformin. The patient received the vaccine on Thursday morning (28Jan2021) and the next day (29Jan2021), her hand was kind of heavy and that night through Saturday (30Jan2021). On an unspecified date, the patient spike very high fever 101 (no unit reported) or something all through non-stop; her armpits and lymph nodes were very swollen. As treatment, patient took Tylenol for the events. The outcome of her hand was kind of heavy was recovered on 30Jan2021, high fever 101 or something was unknown, and armpits and lymph nodes were very swollen was not recovered. The patient stated that she would like to be tested for her immunity before receiving her second dose since she thought that she still have low immunity from Jul2020 because she have been in very long term of Covid.
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| 57 | 2021-03-03 | lymph node swelling |
reports having soreness in left arm at site of injection site. developed loss of appetite that afte...
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reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
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| 57 | 2021-03-03 | swelling |
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of...
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Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
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| 57 | 2021-03-04 | swelling |
became very sore under my armpit and now it is very swollen and sore; became very sore under my armp...
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became very sore under my armpit and now it is very swollen and sore; became very sore under my armpit and now it is very swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot number: 9262) via an unspecified route of administration in the left arm on 31Jan2021 at 09:15 (at the age of 57-years-old) as a single dose for Covid-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included metformin hydrochloride/sitagliptin phosphate monohydrate (JANUMET) and rosuvastatin. The patient previously received first dose of BNT162B2 in left arm on 10Jan2021 at 01:15 PM for Covid-19 immunisation. The patient stated two days after 2nd vaccine, 02Feb2021, she became very sore under her armpit & now it was very swollen and sore. Seriousness criteria was considered as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.
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| 57 | 2021-03-05 | lymph node swelling |
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw...
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I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
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| 57 | 2021-03-05 | swollen extremities |
Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about ...
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Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about 24 hours moted to have rash on right side of neck that developed into two papules by the next day, 36 hours after vaccine started with rash to dorsum of right hand at digits 3,4 with mild edema at base of fingers.
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| 57 | 2021-03-06 | swelling |
First does given 2/5/2021 no reactions except sore arm next day Second dose given 3/5/2021 Headache ...
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First does given 2/5/2021 no reactions except sore arm next day Second dose given 3/5/2021 Headache next day and on 3/7/2021 now have swollen knot on left side of neck, area around somewhat swollen as well.
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| 57 | 2021-03-07 | lymph node pain, lymph node swelling |
painful, swollen lymph nodes in armpit of right arm. feeling much better today, 3-8-21, but pain not...
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painful, swollen lymph nodes in armpit of right arm. feeling much better today, 3-8-21, but pain not completely gone. ibuprofen and acetominophen used to treat.
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| 57 | 2021-03-07 | peripheral swelling, c-reactive protein increased |
Vaccine received from off site facility. Unknown site or lot number. Patient started to experience...
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Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.
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| 57 | 2021-03-08 | anaphylactic reaction |
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain...
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Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
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| 57 | 2021-03-09 | lymph node swelling |
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild,...
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
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| 57 | 2021-03-09 | swelling |
fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itchin...
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fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
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| 57 | 2021-03-11 | lymph node swelling |
Increase in arthritis/joint pains starting day after vaccine; Intermittent headaches. 12 days after...
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Increase in arthritis/joint pains starting day after vaccine; Intermittent headaches. 12 days after vaccine, patient donated blood. 13 days after vaccine with chills, fatigue, body aches, headache, feeling feverish, but normal temperature, right neck gland swollen
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| 57 | 2021-03-14 | swelling |
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (...
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. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
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| 57 | 2021-03-14 | swelling face, swelling | Severe itching, hives, facial and neck swelling, breathing trouble |
| 57 | 2021-03-15 | swelling face | Developed itching and swelling of face and tongue, confirmed SOB. |
| 57 | 2021-03-15 | swelling |
Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribe...
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Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribed Acyclovir for 10 days. Symptoms subsided over time. Some residual itching at times still
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| 57 | 2021-03-18 | lymph node swelling |
Swollen lymph nodes on right side of neck, top of ear, down side of face, down to collar bone, some ...
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Swollen lymph nodes on right side of neck, top of ear, down side of face, down to collar bone, some soreness in armpit
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| 57 | 2021-03-18 | peripheral swelling | Itchy face, red inflamed and itchy hands, ringing of the ears |
| 57 | 2021-03-19 | peripheral swelling | My arm 2 days after the second dose started to itch terribly and became red and swollen |
| 57 | 2021-03-20 | lymph node pain, lymph node swelling |
lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph n...
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lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021. Information regarding lot/batch number has been requested.
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| 57 | 2021-03-21 | swelling | Skin redness and minor swelling. 25mg Benadryl PO |
| 57 | 2021-03-22 | swelling face | Patient presented with progressive facial swelling and shortness of breath |
| 57 | 2021-03-23 | lymph node swelling | rash, red hot under shot arm. Swollen glands under shot arm |
| 57 | 2021-03-23 | peripheral swelling |
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject...
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Redness and swelling of both arms starting at wrists and itching on left arm. Subsided after about 45 minutes. Advised Benadryl, but wanted to wait until she got home as she had a bit of a drive and didn't want to drive drowsy.
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| 57 | 2021-03-23 | swelling face, lymph node swelling |
complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, s...
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complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, sinus problems worse then before and headaches and sore body. right now the sides of my face feels swollen and my lymph nodes are swollen
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| 57 | 2021-03-23 | swelling face |
Vaccine administered on 3/6/2021. On 3/8/21, symptoms of small fiber polyneuropathy greatly amplifie...
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Vaccine administered on 3/6/2021. On 3/8/21, symptoms of small fiber polyneuropathy greatly amplified and continue to present. On 3/12/2021, woke up with left side of face feeling slightly swollen extending from jaw up through eyelid-appearance unchanged, no loss of facial muscle control; sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy. On 3/14/2021, woke up with upper and lower gums feeling slightly swollen across entire expanse (left and right); sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy.
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| 57 | 2021-03-24 | swelling |
Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips a...
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Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips and face with urticaria
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| 57 | 2021-03-24 | lymph node swelling |
Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant sw...
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Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant swelling and tenderness. No other symptoms.
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| 57 | 2021-03-24 | oral herpes |
I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The sym...
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I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The symptoms lasted a few weeks. Most of the symptoms resolved, but I still have areas of weird sensations that has not gone away. For the immediate treatment, I was given a prescription for steroids and was told I shouldn't have any additional problems for future vaccinations. I was scared to get the COVID vaccine thinking I could have another severe reaction, but I was assured it should not happen again. I had the COVID vaccine on 3/10/21. Yesterday, 3/24/21, exactly 2 weeks to the day, I'm feeling like the Bell's Palsy symptoms are returning. I have had a large fever blister on my mouth and one side of my face is feeling somewhat numb.
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| 57 | 2021-03-24 | peripheral swelling, lymph node pain |
Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, un...
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Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.
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| 57 | 2021-03-25 | lymph node swelling, peripheral swelling, swelling |
Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious,...
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Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm. No sore throat, fever.
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| 57 | 2021-03-25 | lymph node swelling | Extreme breast pain, both right and left for six days. Swollen lymph glands in both arm pits. |
| 57 | 2021-03-25 | swollen extremities | Severe Head ache Body aches Temp spike Chilling Lump under arm |
| 57 | 2021-03-26 | lymph node swelling |
day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain ...
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day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain and fatigue - very tired end of day 3 - Lymph nodes swollen - under left arm 4th day lymph nodes swollen in neck and under arm - left side took Tylenol 2 x a day starting day 2 by 7th day, was no Tylenol needed, lymph nodes gradually went down.
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| 57 | 2021-03-27 | peripheral swelling |
left scars to her left breast still, that look like white crust on them/scars on her left breast; le...
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left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
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| 57 | 2021-03-28 | oral herpes |
A massive cold sore developed on my lower lip. I have not had a flare up like this in years. I'm co...
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A massive cold sore developed on my lower lip. I have not had a flare up like this in years. I'm concerned that because I was vaccinated to stop a virus, it is causing my cold sores to flare up? It is unusually painful.
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| 57 | 2021-03-28 | swelling face |
Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approxima...
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Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approximately 10 min after receiving the second dose of her COVID-19 vaccine. This persisted throughout evaluation. She received the first dose of her COVID-19 vaccine 3 weeks prior, without adverse effects. She had progression of symptoms during her evaluation, with some chest pressure, described as a sensation of a brick sitting on her chest, duration approximately 10 min at the time of evaluation, continual, approximately 3/10 on pain scale, persisting chest pressure worse with deep breathing. Oxygen saturations were stable at 95%, anterior breath sounds clear with good air exchange, distant heart sounds. Good peripheral pulses, perfusion difficult to assess since fingertips were cold due to cold external air temperatures. She was transferred from private vehicle to ambulance and oxygen was placed and EKG obtained as below. She was then transferred to hospital for further evaluation. Of note, the patient reported that during the day prior to receiving the second dose of her vaccine, she had worsening shortness of breath with need for supplemental oxygen, 2L by nasal cannula, with activity and at rest. Onset prior to her evaluation after her vaccination. This is above her baseline of nocturnal oxygen use. She was feeling poorly prior to presenting for the vaccine. She had been hospitalized with intubation for CHF exacerbation in the week prior to 2nd dose COVID-19 vaccine administration.
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| 57 | 2021-03-29 | anaphylactic reaction |
Patient complained of itching, said previous anaphylaxis started with a deep itch. Vitals stable and...
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Patient complained of itching, said previous anaphylaxis started with a deep itch. Vitals stable and no shortness of breath. Patient had pre medicated with prednisone and Benadryl. As itching continued urgent care MD ordered epinephrine to be administered
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| 57 | 2021-03-29 | lymph node pain |
I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the...
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I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the worst I felt like I was going to throw up I had pain in my lower right side of my back also pain in my neck lymph node areas also pain in my knees it seems like it targets previous injuries also I had a low-grade fever nauseousness chills couldn't sleep fatigued just terrible feeling this morning is Tuesday March 30th I'm starting to feel better but I still really weak just really weak and my throat has been sore since like Saturday.
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| 57 | 2021-03-29 | swelling face |
Patient developed fatigue shortly after vaccination. Approximately 3-4 hours after vaccination, she...
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Patient developed fatigue shortly after vaccination. Approximately 3-4 hours after vaccination, she developed diffuse facial swelling. There was no dyspnea, tongue swelling, dizziness, hives, itching. She has no history of dermal fillers or other cosmetic facial procedures. She monitored at home, did not seek medical attention. Swelling was resolved by the following morning when she awoke from sleep.
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| 57 | 2021-03-29 | swelling, c-reactive protein increased |
Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain,...
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Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
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| 57 | 2021-03-30 | lymph node swelling, peripheral swelling |
Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a c...
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Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a contactable consumer (patient). 57-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 57 years of age, via an unspecified route of administration on 10Feb2021; 09:30 at single dose for covid-19 immunization. The patient medical history included Obesity, high blood pressure, asthma and unknown if ongoing. No known allergies. Concomitant medication included Amlodipine Besylate, Atorvastatin and Escitalopram. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021;06:00 patient experienced Underarm lymph node swelling, pain, knot on the shot arm only. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
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| 57 | 2021-03-30 | peripheral swelling |
Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 1...
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Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5 on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 57 | 2021-03-31 | lymph node swelling | Lymph Node swelling left armpit Fever Chills Headache Body Aches Nausea |
| 57 | 2021-04-01 | lymph node swelling |
29Mar2021 Approx. 5pm = slight pain at injection site (left upper arm) when I lift my arm 30Mar2021 ...
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29Mar2021 Approx. 5pm = slight pain at injection site (left upper arm) when I lift my arm 30Mar2021 Approx. 1pm = Nasty persistent headache with fatigue 30Mar2021 Approx. 8:30pm = Tiredness + chills. I went to bed. 31Mar2021 Approx. 11am = Felt good except for slight pain in left armpit when I move my arm. 01Apr2021 woke up at 6:30am feeling like I have a golf ball in my left armpit which look swollen compare to my right armpit (no problem here). Additionally, itching, readness on left arm skin 2 inches below vaccine injection site spreading towards my armpit. 02Apr2021 Left armpit still swollen but the golf ball feeling less prominent than the day before.
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| 57 | 2021-04-02 | lymph node pain, lymph node swelling |
Random dizziness, headache and left arm injection site slight swelling. Now under arm area/ armp...
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Random dizziness, headache and left arm injection site slight swelling. Now under arm area/ armpit is slightly swollen and very tender. Started taking ibuprofen for inflammation and headache
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| 57 | 2021-04-02 | swelling |
I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of ...
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I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of nose on fire, as if dipped in hot sauce. Anywhere I touched burned. It felt like it was coming out of my pores, and I jumped into the shower to rinse off, spreading "it" everywhere. The redness and blisters would migrate every hour or so. One minute it was my tongue, then it would show up on my chest. I called the advice nurse who instructed me to take a Benedryl. My tongue and throat were tingling. The Benedryl helped, and I was able to go back to bed but woke up four hours later worse than before. I called again and my PCP was alerted. via email. She prescribed a run of Prednisone and that stopped it, however after the run was over, it started again. A second run of Prednisone was taken. Upon completion, my throat started to tingle again, then stopped. I have pictures of the hives, swelling, and blisters on my tongue, lips, eye, and chest, I cannot take the second dose, per PCP.
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| 57 | 2021-04-03 | peripheral swelling |
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F...
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Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
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| 57 | 2021-04-04 | lymph node swelling |
Lymph node swelling as large as an egg. Pain in underarm and shoulder, neck area as well as injectio...
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Lymph node swelling as large as an egg. Pain in underarm and shoulder, neck area as well as injection site in arm. Fever, chills, muscle aches. Started within 24 hours. Lasted more than 72 hours. Lymph node is still swollen.
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| 57 | 2021-04-04 | lymph node swelling | Lymph nodes in left armpit were swollen and painful. Got better after a few days. |
| 57 | 2021-04-04 | swelling face |
Patient walked into the clinic this morning to report significant LEFT sided facial swelling. She de...
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Patient walked into the clinic this morning to report significant LEFT sided facial swelling. She denied any respiratory distress, difficulty swallowing or any other symptoms at that time. She states she noticed the swelling when she woke up this morning. She had not attempted any OTC medication prior to coming to the clinic. She was ordered to go to the ER for further evaluation and treatment.
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| 57 | 2021-04-09 | swelling face |
my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swo...
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my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swollen/left side of face was slightly puffy; full muscular control of my face; Polyneuropathy symptoms were stirred up; Throat felt slightly itchy; Left upper forearm pain; Pain upper arm; This was a spontaneous report from a contactable consumer, the patient. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 08:11 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy, asthma (very mild), polyneuropathy from Aug2020 and ongoing, anxiety, and sinusitis. Patient was tested positive for Covid in Jan, she tested positive on 14Jan2021. This was a mild case and antibodies were confirmed afterwards. It was 7 weeks after she tested positive that there were confirmed positive antibodies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); gabapentin (MANUFATURER UNKNOWN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED) (MANUFACTURER UNKNOWN) and Wilson's Wash (MANUFACTURER UNKNOWN). The patient previously took theophylline for asthma and experienced swelling face and pharyngeal swelling. On 06Mar2021, the patient experienced throat felt slightly itchy, left upper forearm pain, pain upper arm. On 09Mar2021, the patient experienced polyneuropathy symptoms were stirred up. On 12Mar2021, the patient experienced full muscular control of my face, at 05:30 she experienced left side of face slightly swollen/left side of face was slightly puffy. On 14Mar202, the patient experienced my gums were slightly inflamed or puffy, particularly the upper gums. It was reported that patient received the 1st dose on 06Mar2021 and Friday on 12Mar2021, when woke up, the left side of face was slightly puffy, face looked normal and had full muscular control of face, but it just went form the jaw all the way to the eyelid only on the left side. On 14Mar2021, gums were slightly inflamed or puffy, particularly the upper gums. Patient called neurologist the next day, 15Mar2021, went to see him on Thursday to have him take a look. He confirmed there was no muscular damage, but the left side of my face when poked was duller than the right side. It started 2 weeks ago today, it hasn't gotten worse and hasn't gotten better. Patient was scheduled to get 2nd dose this Sunday but going to hold off because she was concerned about this side effect. Patient tried using Claritin and Benadryl to see if that might make it go away, but it didn't. Her face does not look disfigured in any way. It's not getting worse or better. Just staying the same. She also has polyneuropathy. She got it in Aug2020 from a needle biopsy of the lymph node in her left breast. It was supposed to decrease over time over one or two years. Prior to having Covid she didn't think about it most days. When she got Covid it stirred up the symptoms. When she got the vaccine it also stirred up the polyneuropathy symptoms. She started to notice it being stirred up 09Mar2021. Her neurologist said it was her immune system working and it was aggravating it. On 12Mar2021, she had the left face thing, which was completely new, she never had symptoms like that. It has been 2 weeks and hasn't gotten worse, hasn't gotten better. She was super healthy. She doesn't drink, doesn't smoke, and exercises every day. On the needle biopsy last year by the radiologist in Aug2020. She got small fiber polyneuropathy, which causes tingling prickly sensations in different parts of the body. It was acute form and will go away in a year or two. By Jan it had minimized, but Covid stirred up the symptoms. The neurologist said any illness can cause polyneuropathy symptoms to increase. Then they started to subside. When she got the vaccine, by that Tuesday the polyneuropathy symptoms were greatly aggravated, by the 09. She was confident that they would resolve and have lessen in severity. The clinical outcomes of the left side of face slightly swollen, throat felt slightly itchy was not resolved, for the throat felt slightly itchy, left upper forearm pain was resolved on 06Mar2021, for the pain upper arm was resolved on 07Mar2021 and for event Polyneuropathy symptoms were stirred outcome was resolving. No follow-up attempts are possible. No further information was expected.
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| 57 | 2021-04-17 | anaphylactic reaction |
anaphylaxis, requiring 3 epi pins, emergency transport, ER and inpatient treatment, 2 days hospitali...
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anaphylaxis, requiring 3 epi pins, emergency transport, ER and inpatient treatment, 2 days hospitalization, pcp followup.; A 57-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 13Mar2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and thyroid disorder. Concomitant medications included fluticasone; sodium propionate (PROPIONATE) and levothyroxine sodium. The patient previously took alatrofloxacin, pencillin, bactrim, levaquin and sulfa and experienced known allergies. The patient experienced anaphylaxis, requiring 3 epi pins, emergency transport, er and inpatient treatment, 2 days hospitalization, pcp followup on 13Mar2021 10:15. The patient was hospitalized for for 2 days on an unspecified date. Therapeutic measures were taken as a result of anaphylaxis included epinephrine, breathing treatments, speech therapy. Outcome of the event was unknown.
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| 57 | 2021-04-17 | lymph node swelling, lymph node pain |
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ...
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tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
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| 57 | 2021-04-17 | swelling face |
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q...
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breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
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| 57 | 2021-04-22 | lymph node swelling |
Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain ...
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Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain at injection site; a little rash in right forearm; This is a spontaneous report received from a non-contactable consumer (patient). A 57-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 57-years-old, via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:30 AM (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included Diabetes, Hypertension, Neuropathy, Radiculopathy. No allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride; losartan; atorvastatin (LIPITOR); clonidine (CATAPRESS); clonazepam (KLONOPIN). Patient received first dose of BNT162b2, at the age of 57-years-old, administered in Arm Left on 03Mar2021 10:15 AM (Lot Number: EN6207) for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling lymph nodes in armpit and clavicle on 07Apr2021 21:00 with outcome of recovering, swelling and pain at injection site on 07Apr2021 21:00 with outcome of recovering, a little rash in right forearm on 07Apr2021 21:00 with outcome of recovering. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 57 | 2021-04-24 | peripheral swelling |
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop i...
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Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 57 | 2021-04-30 | swelling face |
She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness o...
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She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered. No Follow-up attempts are needed. No further information expected.
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| 57 | 2021-04-30 | swelling, lymph node swelling |
swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the lef...
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swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the left side of her neck; swelling/swelling went to the back, the shoulder blade up the left side of her neck; redness; pain started at injection site; pain went from her elbow to shoulder and then up her shoulder and up to the neck; pain went from her elbow to shoulder and then up her shoulder and up to the neck/she still has arthritic type pain in left arm socket.; couldn't lift her left arm at all; deep ache/ to her back; crying; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (lot number reported as "EN or W 0161, EN0161 or EW0161") at a single dose for COVID-19 immunisation. Medical history included diabetic from 2008, blood clots , COVID-19 (reported as April; year unknown), insulin dependent in 2014 , Protein S deficiency, genetic disorder that makes her have blood clots, neuropathy. Concomitant medications included warfarin sodium (COUMADIN) taken for Protein S deficiency, genetic disorder that makes her have blood clots from 2007 to an unspecified stop date; gabapentin taken for neuropathy from Sep2019. Patient stated that she gets a mild case of the flu when she gets the flu vaccine, but she doesn't remember back to childhood. She got an MMR booster about 20 years ago and had no problems then. Family Medical History: both parents had diabetes; mother has Protein S deficiency as well that causes blood clots. The vaccine was administered at healthcare facility. The patient did receive previous immunization with a Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received her first shot on Monday 12Apr2021 and was fine until 12 hours later. Her arm swelled up and she couldn't lift it. Then the swelling went to the back, the shoulder blade up the left side of her neck. She could feel her lymph nodes and so she was icing it, taking Tylenol and the swelling has gone down. The redness was gone but she still has arthritic type pain in left arm socket. She can lift and move the left arm, but it hurts, and it also hurts when she turns her head to the right. She received the Pfizer COVID vaccine in her left arm. The pain started at injection site and then went from her elbow to shoulder and then up her shoulder and up to the neck. Her family was commenting on her neck being swollen. She received her shot at 4:30 PM on 12Apr2021. The redness and swelling started at around 5:00 AM on 13Apr2021. A couple hours after Pfizer COVID vaccine injection the pain started. She waited for 30 minutes because she takes coumadin for a history of blood clots, nurse wanted to wait to make sure her arm wouldn't bleed. She has been taking Benadryl ointment and icing it for 3 days as treatment for the events. She got up at two this morning to go to the bathroom and noticed she could still feel the pain when she turns her head to the right. She had swollen submandibular lymph nodes and could feel two of them before. When she woke up, she could not feel her lymph nodes. Everything has recovered except for the pain. The patient stated that on the first day the symptoms were disabling, and she couldn't lift her left arm at all. They got better once she started icing it and rested instead of doing chores. She keeps popping Tylenol every 6 hours, Benadryl and refilling ice bag with one ice bag on neck and one ice bag on arm. There was a deep ache right now in the socket that goes up her neck and down the shoulder blade to her back. Right now, she doesn't like to be in any pain and would say the pain was mild compared to how it was, the pain was so bad she was rocking and crying. Her brother gave her one of her mother's pain pills, one Vicodin because she was in so much pain. She can control the pain now with the extra strength Tylenol. She got the Pfizer COVID vaccine for lots of reasons. She has a lot of health problems, she had COVID virus last April and that was why she was having this reaction since she already has antibodies. She takes care of her mother who was sicker than she was. She was out in the real world and she doesn't want to bring anything home or get anything herself. She thought gabapentin would have made it to where she did not have the arthritic pain from vaccine. She takes gabapentin for neuropathy. She was diabetic and that may have something to do with it too. Patient stated that everyone else in her family got Johnson and Johnson and nobody had reactions. She was supposed to get at the Johnson and Johnson shot first but with the shortage it was switched over the to Pfizer COVID vaccine. This was her first dose of the Pfizer COVID vaccine. Redness and swelling started at around 5:00 AM 13Apr2021. Pain started around 6:30 PM. The events did not require emergency room visit or hospitalization. She was at the urgent care yesterday where she gets her INR checked and the nurse said she didn't see any swelling but believed she was in pain because the she didn't want to lift the left arm. The reporter assessed the events swelling, redness, and pain were considered serious (disabling). Outcome of the events vaccination site pain, neck pain, arthralgia, and back pain was recovering, for event crying was unknown, for event swollen submandibular lymph nodes was recovered on unspecified date, while for events swelling, joint swelling and redness was recovered on 16Apr2021. Information on the lot/batch number has been requested.dft; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
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| 57 | 2021-04-30 | swelling |
headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial bloo...
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headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included osteoarthritis, and migraines. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination. The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-05-08 | sepsis |
Severe joint pain, fevers, severe headaches, cough, severe fatigue, the first week. Second & 3rd wee...
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Severe joint pain, fevers, severe headaches, cough, severe fatigue, the first week. Second & 3rd week -Positive D dimer,low o2 sat.s. high fevers and body/joint pain. 4-6 week-Hemoptysis, Systemic inflammattory response syndrome, sepsis, acute bronchitis, uveitis and vertigo. Info below is for answer 21 1 admissions to Hospital was 4 days 2nd admission to Another Hospital. 6 day stay Most of the treatment was antibiotics, oral steroids, steroid drops for my eyes and breathing treatments to open my airway.
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| 57 | 2021-05-10 | anaphylactic reaction |
Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second C...
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Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second COVID vaccine on Friday. Symptoms consisted of perioral tingling, some possible oral swelling, and then subsequent shortness of breath with labored breathing. Initial treatments in the emergency room did result in some symptomatic benefit, however, the patient continued to have an oxygen requirement and demonstrated persistent symptoms of anaphylaxis. She was then admitted to the intensive care unit for higher level intervention.
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| 57 | 2021-05-10 | lymph node swelling |
Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My a...
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Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My axilla and peck muscle was swollen to 3 times it's size; feel a big swollen node; Flu type symptoms; This is a spontaneous report from a contactable other-HCP (Patient). A 57-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via unspecified route of administration, administered in left arm on 04Feb2021 at 09:30 AM (at the age of 57-years) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), administered at left arm on 12Jan2021 at 09:45 AM as single dose for COVID-19 immunisation. The patient medical history included osteoarthritis. Patient had no known allergies. Concomitant medications included levothyroxine and acyclovir. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021 at 11:30 AM (26-hours after vaccination), patient experienced flu type symptoms and at 09:30 PM (36-hours after vaccine), injection site turned red, hard and swelled up. On 06Feb2021 (morning), axilla and peck muscle swollen to 3 times its size. Patient received ibuprofen and Benadryl for treatment, and it went down a little however, patient can still feel a big swollen node that appeared a day before. No specific treatment was given for swollen node. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was not recovered.
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| 57 | 2021-05-18 | swelling face |
Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When ...
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Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When touching the area there is a lump that measures between an inch and two; Speech is weird; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 04:00 PM in the left arm at 2nd dose, single for COVID-19 immunisation. The patient age at vaccination was 57 Years. Medical history included IBS (inflammatory bowel disease) and recently the patient was developed a sensitivity to shrimp that results in hives. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL9282) received in left arm on 10Feb2021 05:00 PM for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and after the vaccination. On 05Mar2021 7:15 AM, the patient had swelling occurred in the area between my mouth and chin on the left side of my face up and my speech is weird. It almost feels like I went to the dentist and got a shot of novocaine in that area. When touching the area there is a lump that measures between an inch and two. I took two Benadryl at 7:35 or so and the swelling has started to decrease but is still there, as well as the numbness. Therapeutic measures were taken as a result of numbness (hypoaesthesia), swelling occurred in the area between my mouth and chin on the left side of my face (swelling face), when touching the area there is a lump that measures between an inch and two (mass) with Benadryl and novocaine. The patient reported that she do not know if this was happened before but potentially having a reaction to the vaccine that she got on Wednesday part of face has swelled up. Outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 58 | 2020-12-31 | peripheral swelling |
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ...
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Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
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| 58 | 2021-01-03 | lymph node swelling |
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI;...
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12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
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| 58 | 2021-01-05 | peripheral swelling |
Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contac...
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Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL0140), via an unspecified route of administration, on 30Dec2020 at 04:30 PM (at the age of 58-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. Medical history included Allergy induced asthma. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (ESTROGEN) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Sulfa (MANUFACTURER UNKNOWN) and Keflex (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 31Dec2020, the patient reported "Swelling of my arm and hand." The patient did not receive any treatment for the events. The clinical outcome of the events swelling of my arm and hand was recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-06 | lymph node swelling |
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third...
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Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
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| 58 | 2021-01-07 | lymph node swelling |
I had a mammogram on 1/6/2021. The mammogram showed that I had inflamed lymph nodes in my left brea...
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I had a mammogram on 1/6/2021. The mammogram showed that I had inflamed lymph nodes in my left breast, which is the same side on which I received the injection (left arm). I had an ultrasound the same day. The same radiologist read the mammogram and the ultrasound. There were multiple axillary lymph nodes on the left side.
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| 58 | 2021-01-07 | peripheral swelling | Soreness , fatigue , Arm swollen , Sore to the touch . |
| 58 | 2021-01-10 | lymph node pain, lymph node swelling |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-11 | peripheral swelling |
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac...
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1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
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| 58 | 2021-01-11 | swelling, lymph node swelling, oral herpes |
lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swe...
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lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events "redness, swelling and tenderness at injection site" and "slightly itchy scalp" resolved on 25Dec2020, the event "Cold blister on lip" resolved on 03Jan2021. The event "Swelling on the right side of the base of her neck near her clavicles" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-12 | anaphylactic reaction | Systemic: Anaphylaxis-Severe |
| 58 | 2021-01-14 | lymph node swelling, lymph node pain |
Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender...
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Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender. Slight fatigue
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| 58 | 2021-01-15 | lymph node swelling, swollen extremities | Axilla swelling, Reactive lymphadenopathy |
| 58 | 2021-01-15 | oral herpes | Fever chills aching and nausea and diarrhea and fever blister |
| 58 | 2021-01-15 | peripheral swelling |
The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she...
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The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she sat down, she stated she had swollen fingers and hands, and felt chest tightness. She was then transported to the ED in a wheelchair.
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| 58 | 2021-01-18 | peripheral swelling |
Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for im...
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Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for improvement.
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| 58 | 2021-01-19 | lymph node pain, swelling |
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort d...
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Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
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| 58 | 2021-01-19 | lymph node swelling | Swollen lymph node in area of left collar bone and lower neck |
| 58 | 2021-01-20 | lymph node swelling | DEVELOPED LUMP IN RIGHT ARMPIT AND PAIN IN RIGHT ARM MORNING AFTER INJECTION |
| 58 | 2021-01-20 | swelling, swelling face |
I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my ton...
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I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my tongue felt like it was a little swollen. A little later on I felt like something was on my neck so I reached up felt some swelling on my lower neck and shoulder. Before reaching back to work my face felt like it was swelling only on the left side. As the day went by the workers at my school could tell that my face was swelling. Got home called the hospital and the told me to go to the ER. I went and they checked me out and put me on prednisone and benadryl. Second day I still feel like my face feels numb and still have to swelling at the bottom of my neck.
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| 58 | 2021-01-21 | peripheral swelling |
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu...
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Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
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| 58 | 2021-01-21 | swelling face |
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s...
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Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
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| 58 | 2021-01-22 | lymph node swelling |
Extremely enlarged lymph nodes on same side of injection. Supraclavicular. Still present two weeks l...
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Extremely enlarged lymph nodes on same side of injection. Supraclavicular. Still present two weeks later but smaller in size
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| 58 | 2021-01-24 | peripheral swelling |
Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting...
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Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting worse. m Vaccinated on Friday
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| 58 | 2021-01-25 | swollen extremities |
Flu like symptoms, swollen armpit and shoulder pain. Treatment take Tylenol and ice the area. Curren...
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Flu like symptoms, swollen armpit and shoulder pain. Treatment take Tylenol and ice the area. Currently still having symptoms.
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| 58 | 2021-01-26 | lymph node swelling |
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move m...
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Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move my neck, and is very tender to touch. It is still present now, 10 days after receiving the vaccination. I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
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| 58 | 2021-01-27 | c-reactive protein increased |
Fever starting 15 hours after vaccination and continuing for three weeks and still having fever to 1...
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Fever starting 15 hours after vaccination and continuing for three weeks and still having fever to 102
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| 58 | 2021-01-28 | lymph node swelling |
Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit...
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Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit around 2:00 pm and lasted at least 12 hours. Also swollen shoulders and shoulder and back pain. The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back. The shortness of breath occurred agin the next day while working around the home. and lasted about 5 minutes.
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| 58 | 2021-01-31 | lymph node swelling |
Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache,...
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Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache, tired, upset stomach and blisters on my tongue
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| 58 | 2021-01-31 | lymph node swelling |
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic...
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Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
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| 58 | 2021-01-31 | swelling face |
Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid...
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Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid. I?ll still achy.
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| 58 | 2021-02-04 | lymph node swelling, lymph node pain |
Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thur...
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Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thursday, February 4, 2021. Went to my local Urgent Care facility on Thursday , 2/4/21 morning, 9:20am. Diagnosed with Shingles. Prescribed Valacyclovir 1gm BID. Started first dose on Thursday, 2/4/21 at approx. 10:45am. Currently experiencing burning sensation in the area of lesions. Swollen lymph node in right groin area with pain/ache feeling surrounding the right groin lymph node.
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| 58 | 2021-02-04 | peripheral swelling |
2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This inc...
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2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This increased in severity I took nsaids topical steroids Saw rheumatologist who ordered prednisone snd multiple lab tests. Suspect autoimmune reaction triggered by vaccine in some way. Also have migraine
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| 58 | 2021-02-07 | swelling, peripheral swelling |
Edema / swelling from chest down to feet. 1st day after vaccine I noticed some swelling in my fee...
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Edema / swelling from chest down to feet. 1st day after vaccine I noticed some swelling in my feet, 2nd day after vaccine I had 2+ edema in my legs & feet, 3rd day after vaccine I had 3+ pitting edema in my feet and swelling from my chest/abd down to my feet. I initially did not contribute this to the Covid vaccine but thought I was having complications from my surgery. However, I had not had any adverse reactions from my surgery and I had been going to follow up visits weekly with the surgeon. I went to the ER on 1/24/21 because I had gained 13 lbs. in fluid over a 3 day period and thought it could be a DVT or CHF.
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| 58 | 2021-02-07 | swelling | Itchy, swollen skin around eyes, face, ears, neck, under left breast, and arms. |
| 58 | 2021-02-08 | lymph node pain, lymph node swelling |
Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: develop...
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Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: developed Cellulitis in left upper arm at injection site
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| 58 | 2021-02-09 | lymph node swelling |
After about 4 hours, I developed a large swelling of about the size of a goose egg under my right ar...
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After about 4 hours, I developed a large swelling of about the size of a goose egg under my right arm pit on the lymph node. The swelling was painful. I went in to see my doctor the next afternoon at 3:20 p,m, and the swelling had shrunk in half. Soft and moveable. No fever or rash or muscle aches other than the pain of the lump.
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| 58 | 2021-02-09 | peripheral swelling |
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbn...
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Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
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| 58 | 2021-02-10 | axillary mass | Chills lump/soreness in armpit of the arm for the vaccine extreme lower back pain....3 days |
| 58 | 2021-02-10 | lymph node swelling |
Sore throat, headache, cough, neck pain times 2 days. Stated she was fine the first day, second and ...
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Sore throat, headache, cough, neck pain times 2 days. Stated she was fine the first day, second and third day she developed flu like symptoms. On day five, she developed lymph node swelling, severe headache rated 10/10, stated pain is radiating up from ther neck causing her not to be able to turn neck. Temperature 102.3, BP 151/103
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| 58 | 2021-02-11 | swelling face | facial/ tongue swelling, hives, shortness of breath, trouble swallowing |
| 58 | 2021-02-14 | axillary mass |
Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before beg...
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Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before began to resolve. Over next 48 hours resolved completely. Extreme discomfort!
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| 58 | 2021-02-16 | anaphylactic reaction |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
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| 58 | 2021-02-16 | lymph node swelling |
bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache ...
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bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache injection pain tired cough cold low fever pain
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| 58 | 2021-02-16 | swelling |
On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I n...
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On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I noticed my left side of my neck was swollen so I had asked 2of the M.D.'s and a N.P. to check it and they felt 2 lumps along with the swelling and asked me to keep a eye on it, After a few days the swelling in my neck was gone but the lumps were still there so they asked me to contact my PCP which I did and a few days later she ordered a ultra sound which I had done on 2/4/21 and the results showed there were 3 lumps. I was asked by my PCP to wait 2-3weeks to see if they subside and if not she will order a new ultra sound(which I am waiting to hear back from her)
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| 58 | 2021-02-18 | lymph node swelling |
Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. ...
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Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. During that time, I started getting a temp, the highest was 103.3. I called my doctor and she seemed convinced that it was something else because she hadn't seen that reaction before. I then had developed a headache. The fever took several days to go away. My doctor (via phone) told me to take Tylenol. I also had tingling in my right hand, extreme fatigue, joint stiffness and swollen lymph nodes, which remained swollen for at least a week. I was in bed for over 24 hours. It eventually started it get better after a few days. I also had an antibodies test before I got the vaccine and two days later I found out I had positive antibodies--and this was 6 months later (I had COVID in July). I had the same reaction with Dose 2.
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| 58 | 2021-02-20 | lymph node swelling, lymph node pain |
One hour after injection I experienced pain on the right side of my face. My preauricular lymph nod...
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One hour after injection I experienced pain on the right side of my face. My preauricular lymph node is painful and swollen two days after the second Covid vaccine.
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| 58 | 2021-02-23 | peripheral swelling |
Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021...
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Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021.
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| 58 | 2021-02-28 | lymph node swelling |
Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a sponta...
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Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a spontaneous report from a contactable other healthcare professional (the patient). A non-pregnant 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscular in the left arm, on 17Jan2021 at 08:30 AM (at the age of 58 years) as a single dose for COVID-19 immunization. Medical history included high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included estradiol (ESTROGEN), pravastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00 PM, the patient developed large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon. The event was reported as non-serious. Therapeutic measures were taken as a result of large painful lymphadenopathy on left side of neck near clavicle, the size of a lemon. The clinical outcome of the large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-02-28 | lymph node swelling |
24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fe...
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24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fever 101 Extreme fatigue Brain fog - or difficulty focusing on work related tasks These symptoms resolved within 24 hours, 3 days after the 2nd injection I developed a lemon sized nodule in my arm pit that was mildly painful to touch. This resolved within 3 days.
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| 58 | 2021-03-01 | lymph node swelling |
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel...
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Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
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| 58 | 2021-03-02 | peripheral swelling |
lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of...
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lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of both hands. unable to grasp with both hands, dark spot in middle of hand.
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| 58 | 2021-03-03 | lymph node pain | Right Under arm Lymph node and right breast discomfort/ pain |
| 58 | 2021-03-04 | swelling face |
Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief...
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Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief. She was given cetirizine to take after she was examined the day following her vaccine.
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| 58 | 2021-03-10 | lymph node pain, lymph node swelling |
After a few days past the first dose, I noticed a pain on the left side of my chest near my armpit. ...
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After a few days past the first dose, I noticed a pain on the left side of my chest near my armpit. Through palpation my primary care dr noticed a large swelling which was very painful when she pressed down on it. She sent me for a diagnostic mammogram which was completed with no issue noted by the radiologist. The technician mentioned that the vaccine has caused lymph node swelling in some women. After about 1.5 more weeks the pain went away.
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| 58 | 2021-03-11 | lymph node pain | painful lympnoes |
| 58 | 2021-03-12 | lymph node swelling | Fever, headache, fatigue and swelling in armpit about size of ping pong ball |
| 58 | 2021-03-14 | lymph node swelling |
Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, ...
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Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, and hand swelling.
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| 58 | 2021-03-14 | swelling face |
I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vacc...
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I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021. I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only). Went to bed approx. 10:30 PM and experienced mild chills. I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives. I took a Zyrtec. The itching of hives subsided in approx. 30 minutes. The facial swelling and lower lip swelling subsided in approx. 12-hours. I took and have photos of my face and lips.
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| 58 | 2021-03-15 | lymph node pain, lymph node swelling |
The adverse event occurred the next morning when the pain from the injection sight on the left upper...
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The adverse event occurred the next morning when the pain from the injection sight on the left upper arm felt like it moved into my armpit and left side lymph nodes. Very painful accompanied it. The day after that the lymph nodes in my left collarbone area became swollen and painful with an increased fever, chills, headache that lasted for a week. I got the vaccine on a Thursday (3/4/21) and went to my doctor on Monday (3/8/21) to get checked out. This was only my first vaccine. I had a bad case of Covid-19 in June-July 2020 and my husband passed from Covid-19 at that time. I still have swelling in my left collarbone lymph nodes today.
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| 58 | 2021-03-16 | peripheral swelling |
swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks...
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swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks painful/Fingers hurting, I am cutting and dropping things more frequently; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9899) intramuscularly in the left arm on 26Dec2020 at 08:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included migraine from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received epinephrine on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 06:00 the patient experienced swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently. The events all resulted in doctor visits and were all serious for disability or permanent damage. The clinical course was reported as follows: "I developed swollen fingers, joint started hurting. My both hand fingers were drum sticks painful (as reported). I had no idea what was going on, things getting my ankle knees (as reported). I consulted internal medicine; I was referred to Rheumatology Clinic. All blood work was negative. All serology testing done was negative. Joints hurting. The doctor asked me to start taking Motrin which made my situation worse. I gave up. Miserable situation. I consulted another FPC who advised I give it time. I cannot hold fine item. Fingers hurting, I am cutting and dropping things more frequently. I am a healthy person. No medication. No complications." The patient asked if there were any solutions. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9231) intramuscularly in the left arm on 15Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. The patient received treatment for the adverse events which included Ibuprofen 400mg for pain. The clinical outcomes of the events swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-03-16 | swelling |
Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, t...
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Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, tired
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| 58 | 2021-03-18 | axillary mass, lymph node swelling |
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu...
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arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
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| 58 | 2021-03-18 | lymph node swelling | The next day after vaccine chills, vomiting and swollen lymph nodes of left armpit |
| 58 | 2021-03-18 | peripheral swelling | I had a sebaceous cyst on my left ring finger it was a big bump but later that night it was gone |
| 58 | 2021-03-18 | swelling face |
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog...
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hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
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| 58 | 2021-03-19 | swelling face | Fever 102.7, chills, swollen face, feeling unwell, muscle pain, headache, pain |
| 58 | 2021-03-20 | lymph node swelling |
Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This i...
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Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This is a spontaneous report from a contactable Other-HCP (patient). A 58-year-old female started to receive dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: Ek573), via an unspecified route of administration on 11Jan2021 3:30 Pm in left arm, dose number: 1 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: En5318) on left arm, dose number: 2, on 02 Feb 2021 as single dose. The patient medical history included allergies to Penicillin. The concomitant medications included Estrogen (ESTRADIOL), medroxyprogesterone, venlafaxine, alpraz (ALPRAZOLAM) at an unspecified date at an unknown dose. The patient experienced Sore swollen lymph nodes in her underarm left side. Swollen sore lymph nodes groin both sides on 03Feb2021, 05:00 AM. The outcome of events was recovered.
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| 58 | 2021-03-20 | swelling face |
Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of m...
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Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-03-21 | axillary mass |
About 9 hours after injection, the site started to ooze clear liquid. A perfect small circle of skin...
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About 9 hours after injection, the site started to ooze clear liquid. A perfect small circle of skin appeared to be burned off. I cleaned it. Next morning still oozing. Now it is scabbing over day on day 3 Armpit feels like I have a golfball in it.
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| 58 | 2021-03-21 | lymph node pain |
I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, col...
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I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, collarbone - also had pressure on collarbone, sensitive to touch, and some cough. Pressure and cough have subsided this morning , pain is still present. It hurts once in a while when swallowing and neck area I checked the lymph nodes at hurt some (I examined my neck like a doctor would to feel for possible swollen lymph nodes but can't tell if they are swollen or not). I put "no" under recovered because the pain is still there.
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| 58 | 2021-03-24 | peripheral swelling |
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ...
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Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
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| 58 | 2021-03-24 | swelling face, anaphylactic reaction |
58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfiz...
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58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfizer vaccine yesterday. Today awoke feeling funny, felt some tightness in throat, trouble swallowing, more sob, palpitations, headache. When she arrived at work this morning, started dry heaving very nauseated and had to go home. Driving home, she saw her face and noticed it was swollen. No prior hx of allergic reactions. No other new meds or foods in that time. No chest pain. 58F with likely allergic reaction anaphlyaxis to pfizer vaccine. No severe facial swelling, tongue swelling, wheezing but symptomatically concerning given throat tightness, subjective facial swelling (I did see some mild periorbital edema but unable to observe other differences but she could). Not on any ace inhibitor. Less likely chf, acs, pna/ ptx, asthma Pt symptomatically improved a lot after epi, benadryl Observed and deemed stable Dc with prednisone and pepcid
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| 58 | 2021-03-25 | swelling, swelling face |
58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from do...
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58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from doxycycline), seasonal allergy, mild intermittent seasonal asthma developed facial angioedema, erythematous, non-pruritic macules on her face/chest, and a "tiny bit" of chest tightness 5 hours after Pfizer vaccine. Responded to benadryl. 24 hours later facial swelling returned. On 3rd day after vaccination, swelling had fully resolved. No history of dermal fillers. No history of miralax use. Has tolerated influenza vaccine. No recent other vaccines. Skin testing to miralax, methylprednisolone and triamcinolone was negative. I advised her to avoid second dose of Pfizer vaccine.
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| 58 | 2021-03-25 | lymph node swelling |
Headache. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Overall achiness. 1...
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Headache. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Overall achiness. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Axillary lymphadenopathy. 36 hours after shot and continuing. No treatment.
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| 58 | 2021-03-25 | peripheral swelling |
Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headac...
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Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headache,. nausea,. feel tired no energy
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| 58 | 2021-03-25 | peripheral swelling |
Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on l...
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Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on left arm injection site
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| 58 | 2021-03-27 | swelling | Hives, swelling, itching started at 10:15am. |
| 58 | 2021-03-28 | swelling face |
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and chee...
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Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip. Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.
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| 58 | 2021-03-29 | lymph node swelling |
Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pa...
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Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pain/ Large golf ball size nodule on collar bone (lymph gland?); Fever 101 for 3 days; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FN6198 or EN6198 and Expiration date were not provided) on 02Mar2021 15:15 via unspecified route of administration in left arm at SINGLE DOSE for COVID-19 immunization. The patient's medical history included stage 4 metastatic breast cancer, allergies to Penicillin and Cephalexin. The patient's concomitant medications included palbociclib (IBRANCE), letrozole and cetirizine hydrochloride (ZYRTEC). On 07Mar2021, the patient experienced cellulitis in left arm, painful spots in arm as if a bruise but not bruised but knots in arm where there was pain, bright red in left arm and felt hot from elbow to hand, severe swelling of left arm from elbow to hand, peeling of skin on left forearm, large golf ball size nodule on collar bone (lymph gland), fever 101 for 3 days and headache. The patient visited doctor or other healthcare professional office due to events and treated with antibiotics. The patient did not take other vaccine in four weeks. The patient did not have Covid prior to vaccination and not tested post vaccination. At time of report, the patient was recovering from all the events. Information on the lot/batch number has been requested.
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| 58 | 2021-03-30 | lymph node pain | Extremely painful lymph node behind right ear. |
| 58 | 2021-03-30 | peripheral swelling, swelling, swelling face |
numbness, tingling and swelling on the right side of face and head down right arm and chest; numbnes...
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numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
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| 58 | 2021-03-30 | peripheral swelling |
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ...
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Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
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| 58 | 2021-03-30 | swelling face |
allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while dri...
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allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while driving home, somehow missed her exit; face is swollen; fast heartbeat; heart racing really fast; This is a spontaneous repot from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), intramuscular in the muscle of upper left arm (deltoid left) on 03Mar2021 17:15 at a single dose for COVID-19 immunization. The vaccine was administered at a pharmacy, not a facility. No other vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history included hormone replacement therapy, high blood pressure, and "very sick she guessed from a cold and had asthma" on 2011 (from 10 years prior to the report; this was the only time she had asthma, and her physician said her asthma can come on because of being sick). The patient stated that she generally has higher blood pressure than she would like, but she is otherwise very healthy, and never had an allergic reaction to anything. Family history relevant to the adverse events was none. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) for high blood pressure, valacyclovir (VALACYCLOVIR), rosuvastatin (ROSUVASTATIN), omega-3 nos (OMEGA-3 NOS, capsule), estrogen (ESTROGEN) for Hormone replacement therapy, progesterone (PROGESTERONE, 100 mg capsule) for Hormone replacement therapy, all were from unspecified date and ongoing. It was reported that patient gets her flu shot every year and never had an adverse reaction. The patient reported that she had an allergic reaction to the first dose of PFIZER-BIONTECH COVID-19 VACCINE she received last Wednesday (03Mar2021) after an hour after she received it (18:45) while driving. She mentioned that she saw on the package insert what a severe allergic reaction would include. She experienced swelling of the face and a fast heartbeat but no difficulty of breathing on 03Mar2021. The patient further explained that she had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 03Mar2021 around 17:15 at a pharmacy. She left the pharmacy around 17:30. While she was driving home, she started to feel her heart racing really fast and felt like her throat was constricting within about 30 minutes of being administered the vaccine, by around 17:45. She was very flustered while driving home which is usually about 30 minute drive; but somehow she missed her exit and it was rush hour so it was about 18:15 when she got home. When she got home her husband asked her if she had been crying because he said her face looked weird. She told him he thinks her face is swollen. All of these events lasted maybe 1-2 more hours or less after she got home around 18:15, maybe a few hours before she recovered completely. She was expecting soreness and pain from the PFIZER-BIONTECH COVID-19 VACCINE but was not expecting the fast heartrate or swelling. She was reading through the information she got from the pharmacy for the PFIZER-BIONTECH COVID-19 VACCINE because she was a little concerned about getting the second dose due to these events. She has never had an allergic reaction to anything before and wondered if she should go to a hospital for her second dose of the PFIZER-BIONTECH COVID-19 VACCINE in case she has these events again, or a worse reaction. She asked about these events and dosing recommendations for the Pfizer. The reported adverse events did not require a visit to the emergency room or physician office. The patient was not hospitalized. Outcome of the events was recovered on 03Mar2021.
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| 58 | 2021-03-31 | lymph node swelling |
Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased...
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Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased after getting the 1st dose.
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| 58 | 2021-03-31 | lymph node swelling |
Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tigh...
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Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tighter, i.e., labored breath slightly, felt like heart was racing for a few seconds. Sat down and waited for 10 minutes. Feelings subsided. Did not report this to the pharmacist.
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| 58 | 2021-03-31 | lymph node swelling |
I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. I...
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I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. In AM I woke up and felt ill. Throughout the day my temperature went up to 102 by the afternoon. I had headache, bad muscle pain and aches and generally felt miserable. Also, the gland under my arm pit was extremely swollen for 3 full days the size of a baseball. It hurt to rest my arm to my side. That second night, I took fever reducer before I went to bed. Fever broke and I soaked through 3 pairs of pjs. The next day my fever went up to 100.7. I didn't take any more fever reducer. Third day it went up to 99.7. Fourth day normal temp but then I had extreme fatigue starting fourth day to where I barely had energy to sit up or even walk to the bathroom. I tried to do my online remote work that week but only worked 1/3 my schedule due to extreme fatigue. One day I was in the kitchen and had to drop to the floor and rest to get enough energy to walk back to my bedroom. The extreme fatigue lasted a good 5-6 days then the following week I pushed through my online work without reducing my hours but would go straight to bed right afterwards due to fatigue. I have struggled with Epstein Barr virus since I was 23 and get fatigued after getting strep or exercising too much or other illnesses so chalked it up to the EBV. I still had minor stabbing pain under my armpit until the past couple of days. My energy is now back to normal.
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| 58 | 2021-03-31 | lymph node swelling |
Nausea, headache day after injection. 1/2 baseball size swelling under right arm 2 days after inject...
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Nausea, headache day after injection. 1/2 baseball size swelling under right arm 2 days after injection
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| 58 | 2021-03-31 | peripheral swelling | Sore arm, migraine, fingers swelling |
| 58 | 2021-04-01 | swelling |
1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a ras...
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1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a rash, super bright red, that covered where clothing was under my scrubs on my legs, partly on arm. Lasted until Friday afternoon, 1/22. Hives plus red areas. It did expand to my face, beyond where clothing was. It was not itchy, swollen uncomfortable. 1/22 Dermatologist. They took pictures and compared to the pictures online with the CDC. The doctor stated I should not take any more vaccines based on what we know right now with the vaccines. I did go see an allergist. Dr. stated needed pics and notes. And she said yes, you should NOT have any more vaccinations. I kept taking the Zyrtec for week and half.
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| 58 | 2021-04-02 | lymph node swelling |
Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to be...
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Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to bed and woke up an hour later to a severe headache. Through the night I had fever (100.7), chills, muscle aches which kept me up all night. Around 1:00 pm the following day I finally started to feel better. Rested throughout the day and slept fine that evening. The next day I woke up with a swollen lymph node under the armpit of my left arm which received the vaccine. That tenderness went away around three days later.
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| 58 | 2021-04-02 | swelling face, swelling |
3 weeks after second dose, March 20 2021 started with severe hives all over the body, including scal...
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3 weeks after second dose, March 20 2021 started with severe hives all over the body, including scalp and face, swelling. Presently on: Prednisone, Levocetirizin-E, Pepcid, Triamcinolone cream.
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| 58 | 2021-04-03 | lymph node swelling |
six days after my 1stPFZER dose93/23/2021 I had cold chills,fever ,headache ,swollen lymph nodes,ve...
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six days after my 1stPFZER dose93/23/2021 I had cold chills,fever ,headache ,swollen lymph nodes,very bad lower abdominal pain(I almost went to the emergency room for)but did not seek a doctor as the severe abdominal pain eased up after 48 hours as wells as the other symptoms
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| 58 | 2021-04-03 | lymph node swelling |
headache; sore throat; swollen glands on right side of throat; This is a spontaneous report from a c...
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headache; sore throat; swollen glands on right side of throat; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19261), intramuscularly in left arm on 04Feb2021 at 08:00 as a single dose for COVID-19 immunisation. The patient's medical history included osteoporosis, essential tremor, right hip replacement; All from an unspecified date in 2019 to an unspecified date. Concomitant medications included other medications in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E41284), intramuscularly in left arm on an unspecified date in Jan2021 at 14:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation, codeine, and experienced known allergies: Codeine, meloxicam and experienced known allergies: Meloxicam, erythromycin and experienced known allergies: Erythromycin. No COVID prior vaccination. No other vaccine in four weeks. No COVID tested post vaccination. On 14Feb2021 at 06:00 AM, the patient experienced headache almost daily since #2 (just suttle), sore throat and swollen glands on right side of throat 11 days after #2. The patient was treated with over-the counter treatment for the events. The outcome of the events was recovering.
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| 58 | 2021-04-03 | swelling face | Left side of my face swollen up. Left Jaw muscle swollen. Last one day, full recovery on second day. |
| 58 | 2021-04-04 | lymph node swelling |
Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right ...
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Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right axilla
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| 58 | 2021-04-09 | peripheral swelling |
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming....
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developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-04-18 | guillain-barre syndrome |
Guillian-Barre Syndrome; Back pain; muscle weakness; muscle strain; This is a spontaneous report rec...
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Guillian-Barre Syndrome; Back pain; muscle weakness; muscle strain; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 58-years-old, administered in Arm Right on 17Mar2021 10:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included scoliosis. The patient was not pregnant. Concomitant medications included cranberry (CRANBERRY) and plantago ovata (PSYLLIUM HUSK [PLANTAGO OVATA]), both taken for an unspecified indication, start and stop date were not reported, and an unspecified multivitamin. The patient previously took MACROBID [nitrofurantoin] and experienced allergies. The patient experienced back pain and muscle weakness on 17Mar2021 23:00, for over 12 days. Went to ER and was admitted to local hospital but discharged after 1 day with dx (diagnosis) of muscle strain in 2021. Symptoms worsened, went to PCP which led to diagnosis of Guillian-Barre Syndrome in 2021 and five days hospitalization for IVIG therapy. The patient was hospitalized for Guillian-Barre Syndrome from 2021 to 2021 for 5 days and for muscle strain, back pain and muscle weakness from 2021 to 2021 for 1 day. The adverse events muscle strain, back pain and muscle weakness resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of Guillian-Barre Syndrome which included IVIG therapy. The outcome of the events was recovering. The events were considered as serious (hospitalization). Facility where the most recent COVID-19 vaccine was administered was School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the batch/lot number has been requested.
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| 58 | 2021-04-21 | swollen extremities |
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve...
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inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
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| 58 | 2021-04-24 | swelling face |
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my...
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She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
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| 58 | 2021-04-24 | swelling face |
Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Moment...
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Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
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| 58 | 2021-04-24 | swelling face |
Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable c...
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Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on the left arm on 26Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thyroid disease, HBP (high blood pressure), mild depression, ADD (attention deficit hyperactivity disorder), and migraines. Patient was not pregnant. There no other vaccine in four weeks. Other medication were taken in two weeks. The patient previously took sumatriptan (IMITREX) and zolmitriptan (ZOMIG) and experienced allergy. The patient experienced shortness of breath, itching/hives, face swollen on 27Mar2021 14:00 that resulted in clinic/ emergency room visit. Patient was given IV steroid, Benadry, Prilosec at hospital. Patient was not diagnosed with covid prior to vaccination and had been tested (nasal swab) post vaccination on 28Mar2021 with negative result. Outcome of the events was recovered with sequel.
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| 58 | 2021-04-25 | c-reactive protein increased |
101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2...
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101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2021 at 0500. Felt much better & no fever only problem was bilateral Lumbar pain. This pain was mild at first then worsened in the next two weeks also radiating to bilateral hips and buttock. Worsening stiffness and loss of range of motion. Bending over or lifting legs particularly thighs to get in and out of my car was very difficult & painful. Got MRI of the back with was negative.Orthopedic Surgeon?s PA I saw. She felt it was probably a lumbar strain from possible exercise I had done.. Symptoms improved after activity & PT but returned in a day or so & worsened at a night. In the last month spread to shoulders. Got my Internist involved then. Inflammatory markers done 4/13/2021. C Reactive Protein positive at 2.8. Slightly anemia as well. All other markers negative. Polymyalgia Rheumatica diagnosed. Started on Prednisone 20mg 4/14/2021. Symptoms improving greatly.
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| 58 | 2021-04-27 | lymph node swelling |
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was goin...
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after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
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| 58 | 2021-04-30 | lymph node swelling, lymph node pain |
swollen lymph nodes that are "extremely swollen and very painful."; swollen lymph nodes that are "ex...
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swollen lymph nodes that are "extremely swollen and very painful."; swollen lymph nodes that are "extremely swollen and very painful."; she has incredible pain; fever; experienced shivering that wouldn't stop; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was experiencing swollen lymph nodes that were "extremely swollen and very painful." She had incredible pain and it was hard for her to put her arm down or to reach forward or backwards. On 10Apr2021 she had a fever and experienced shivering that wouldn't stop. The event outcome was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained
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| 58 | 2021-05-02 | axillary mass |
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge...
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1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
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| 58 | 2021-05-10 | lymph node swelling |
After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got ...
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After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got antibiotics. Nine days after the vaccine I got Bells Palsy and I have not been able to work since then. I noticed when I gargled that night the water was coming out. The following day was a holiday and everything was closed. I was able to see my doctor. My left eye was not closing and I had difficulty eating because the left side of my face was effected. I had to tape my eye shut at night. It is very sad and upsetting because I don't know if it will get better. I have seen a Neurologist. It has been four months and I am still getting therapy for the Bells Palsy. Physical therapy since 04/19/2021 with electrical stimulation. My eye closes a little better and my smile is a little straighter.
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| 58 | 2021-05-14 | lymph node swelling |
Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different par...
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Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature: swings from cold to hot on 05May2021. The outcome of all events was not recovered.
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| 58 | 2021-05-17 | swelling face |
This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patien...
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This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EN0161) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergy. After getting shot about 1/2 hr later tongue on right side started going numb and right side of face started to swell on 16Apr2021 17:30. Therapeutic measures were taken included steriods and antihistamine. Patient visited doctor or other healthcare professional office/clinic visit for events. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-05-19 | sepsis |
3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian...
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3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection. She remained on mechanical ventilation, with profound metabolic acidosis. She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98. The patient had a cardiopulmonary arrest in the intensive care unit. 1 round of ACLS protocol was performed, with return of spontaneous circulation. After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death. The patient was kept on mechanical ventilation, and she passed away.
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| 59 | 2021-01-02 | lymph node swelling |
Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe ...
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Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.
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| 59 | 2021-01-04 | anaphylactic reaction |
after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just fel...
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after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms
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| 59 | 2021-01-04 | anaphylactic reaction |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | swelling |
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ...
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pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
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| 59 | 2021-01-05 | lymph node swelling, peripheral swelling |
Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of...
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Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020. No follow up attempts are needed. No further information is expected.
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| 59 | 2021-01-05 | lymph node swelling |
On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very...
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On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on
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| 59 | 2021-01-05 | swollen extremities |
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ...
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6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
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| 59 | 2021-01-05 | peripheral swelling, swollen extremities |
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ...
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1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
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| 59 | 2021-01-06 | lymph node swelling |
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore...
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stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
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| 59 | 2021-01-06 | swelling face, swelling |
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the...
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Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
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| 59 | 2021-01-06 | swelling face |
Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelli...
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Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.
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| 59 | 2021-01-07 | lymph node swelling |
1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body...
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1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
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| 59 | 2021-01-07 | oral herpes | Oral Herpes outbreak, severe |
| 59 | 2021-01-09 | swelling |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-10 | lymph node swelling, lymph node pain |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-10 | swelling |
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o...
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sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
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| 59 | 2021-01-11 | c-reactive protein increased, swollen extremities |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | lymph node swelling |
swollen axillary lymph nodes on the same side vaccine was given. Prescribed Ibuprofen 600 mg tablet...
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swollen axillary lymph nodes on the same side vaccine was given. Prescribed Ibuprofen 600 mg tablet by primary physician
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| 59 | 2021-01-12 | lymph node swelling, lymph node pain |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-13 | lymph node swelling |
Multiple, large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm ...
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Multiple, large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm as vaccine given; severe aches and pains in neck and upper back; severe aches and pains in neck and upper back; This is a spontaneous report from a contactable nurse (patient). A 59-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration right arm on 21Dec2020 12:00 PM at a single dose for covid-19 vaccination. Medical history included latex allergy. The patient's concomitant medications were not reported. The patient previously took telithromycin (KETEKS) and clonidine, but both had allergies. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient reported that she had multiple large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm as vaccine given, severe aches and pains in neck and upper back on 27Dec2020. The patient did not received treatment for the adverse event. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
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| 59 | 2021-01-13 | swelling face |
The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injec...
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The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injection. She denies any other symptoms. Denies itching or pain of area. Denies swelling of tongue or throat. Denies shortness of breath. Was seen by her PCP and symptoms were attributed to angioedema due to ACEi medication.
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| 59 | 2021-01-14 | anaphylactic reaction |
At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bp...
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At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bpm and O2sat 100%. A rapid response code for an anaphylactic reaction was activated at 9:35am. Patient was transferred to the ER vital signs were BP 173/123mmHg , HR 106 bpm, Dxt 93 and O2sat 94%. One dose of Epinephrine 0.3mg IM, D5W 20g/250ml IV, Benadryl 50mg IV and Solu-Cortef 200mg IV were administrated.
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| 59 | 2021-01-14 | swelling face |
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi...
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Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
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| 59 | 2021-01-18 | lymph node swelling |
I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pai...
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I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pain on the left side of my breast and armpit area. I felt my lymph nodes and they are swollen as well. I stopped wearing a bra because it was painful.
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| 59 | 2021-01-18 | lymph node swelling |
Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self admin...
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Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self administrating Benadryl at home. Pt also has bilateral lymphadenopathy in her armpits.
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| 59 | 2021-01-19 | lymph node pain |
48 hours after second vaccine I woke up with pain under my left arm (arm I got the vaccine in) lymph...
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48 hours after second vaccine I woke up with pain under my left arm (arm I got the vaccine in) lymph node. Sore and tenderness lasted 24 to 36 hours.
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| 59 | 2021-01-20 | swelling face |
left side of face swelling, especially left eye area and around left side of mouth; This is a sponta...
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left side of face swelling, especially left eye area and around left side of mouth; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EKG9231, expiration date: not reported), via an unspecified route of administration, on 12Jan2021 10:00 AM on left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at a hospital. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gerd (Gastroesophageal reflux disease) and allergy to grapefruit. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: Elo 140, expiration date: not reported), via an unspecified route of administration, on 23Dec2020 09:00 AM on left arm for COVID-19 immunization. The patient experienced left side of face swelling, especially left eye area and around left side of mouth, on 13Jan2021 11:00 PM. Since the vaccination, the patient has been tested for COVID-19: Nasal swab on 01Oct2020 (as reported) with negative result. The treatment received for the adverse event was Otc (over-the-counter) Benadryl. Outcome of the event was recovering.
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| 59 | 2021-01-21 | anaphylactic reaction |
Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Sys...
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Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
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| 59 | 2021-01-21 | lymph node pain, lymph node swelling |
WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SI...
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WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SIZE OF AN HALF DOLLAR. THE LYMPH NODE ON MY RIGHT SIDE IS ALSO SWOLLEN. ON DAY 2, I HAD FLU LIKE SYMPTOMS WITH A FEVER OF 100.8 THAT SUBSIDED WITH TYLENOL. THE INJECTION SITE BECAME ITCHY ON DAY 3 AND IS STILL RED, WARM, SWOLLEN AND THE SIZE OF AN EGG AND MY LYMPH NODE IS STILL SWOLLEN AND SORE.
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| 59 | 2021-01-21 | swelling |
Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) m...
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Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) middle and (3)ring finger a couple days afterward. Started to go away. Received second dose of COVID-19 on 1/11/2021. Rash continued to worsen. Noticed red rash on neck starting around 1/17/2021. Describes as "just a few red bumps and really itchy". "It felt like poison ivy itching". 1/20/2021, rash appeared to look like hives, swelling, and itchiness intensified. 1/22/2021, swelling subsided some, continues with rash and itchiness.
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| 59 | 2021-01-24 | swelling face |
Patient received COVID-19 vaccine (unknown which manufacturer or lot) and began noticing swelling in...
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Patient received COVID-19 vaccine (unknown which manufacturer or lot) and began noticing swelling in her cheeks and nose nearly immediately. She denies any SOB. Symptoms self resolved in about half an hour and she is currently feeling fine. She does have swelling if she takes Naprosyn containing products. Patient reports vaccine was given on 1/22/21 and second dose is scheduled for 2/15/21 and is not sure if this will be contraindication for her second dose.
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| 59 | 2021-01-25 | lymph node swelling |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-26 | lymph node swelling |
swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other he...
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swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced allergies to ciprofloxacin. The patient had not been tested for COVID-19 since the vaccination. The patient experienced swollen lymph nodes under arm of injection on 11Jan2021 08:00. No treatment was received for the adverse event. Outcome of the event was not recovered.
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| 59 | 2021-01-26 | lymph node swelling |
Large, painful cervical adenopathy and painful swallowing limited to L side, onset 1 d after receipt...
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Large, painful cervical adenopathy and painful swallowing limited to L side, onset 1 d after receipt, severe X 5 d, cervical adenopathy persistent at d 10
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| 59 | 2021-01-26 | lymph node swelling | Swelling of Lymph nodes under arm on side of injection Chills |
| 59 | 2021-01-26 | oral herpes | nause, stomach cramps, fever blisters, lethargic, weakness |
| 59 | 2021-01-26 | peripheral swelling |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-27 | lymph node swelling | Back and joint pain Lymph node swelling Injection site swellingf Fever |
| 59 | 2021-01-28 | lymph node swelling, lymph node pain |
Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside...
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Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-28 | peripheral swelling |
Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of...
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Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of an orange; Headaches; Tiredness; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 59-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ibuprofen. The patient previous received first dose of bnt162b2 (lot number: EK5730) intramuscularly in left arm on 21Dec2020 11:30 AM for COVID-19 immunization. The patient experienced swelling and redness of the arm, the size of an orange, headaches, tiredness, feeling unwell on 13Jan2021 06:00. No treatment received. The outcome of events was resolving. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No covid prior vaccination. No covid tested post vaccination. Not known allergies. Facility type vaccine was hospital. No other vaccine in four weeks.
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| 59 | 2021-01-31 | lymph node swelling |
Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,hea...
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Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,headache, nausea, Ibuprofen every 12 hours with Tylenol in between. Warm compresses
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| 59 | 2021-02-01 | lymph node swelling |
Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that...
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Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that evening felt exhausted after work, fell asleep around 6:30 pm woke up around 8 pm and went to bed around 9:30 pm took Aleve for achy body. Friday morning, Jan 27th woke up with left arm pit and side of left breast swollen, tender to touch. and left arm very sore to lift up. Apply cold packs, taking Tylenol and area of tenderness lasting multiple days.
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| 59 | 2021-02-02 | anaphylactic reaction |
Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart p...
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Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart pain and shortness of breathe which started within 15 minutes of the injection. The heart pains lasted 8-10 days. Headache, fatigue and shooting muscle pains throughout the body starting 2 hours after injection and lasting 8-10 days.
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| 59 | 2021-02-03 | lymph node swelling | Woke with lymphadenopathy and tenderness left supraclavicular area |
| 59 | 2021-02-03 | lymph node swelling |
Swollen lymph node. Noticed breast tenderness the night of receiving vaccine. Breast area tenderne...
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Swollen lymph node. Noticed breast tenderness the night of receiving vaccine. Breast area tenderness. Noticed lump Sunday, 1/31 AM. As of today, significantly smaller, but still there. If I had not just had a mammogram, would have thought it was some rapid growing breast cancer.
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| 59 | 2021-02-03 | lymph node swelling |
Due to my personal history of atypical cells in left breast, I had my routine annual MRI the day aft...
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Due to my personal history of atypical cells in left breast, I had my routine annual MRI the day after my vaccine booster. the MRI noted two enlarged lymph nodes.
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| 59 | 2021-02-04 | peripheral swelling |
Patient reported swelling started in knuckles of both hands 2 days after receiving the vaccine, cont...
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Patient reported swelling started in knuckles of both hands 2 days after receiving the vaccine, continued to worsen until date she received the second dose. Described as throbbing, feels like arthritis.
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| 59 | 2021-02-04 | swelling |
Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and finge...
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Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and fingers, numb feeling, tingling for about a week. Still have.
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| 59 | 2021-02-06 | anaphylactic reaction |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
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| 59 | 2021-02-06 | swelling face | Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea |
| 59 | 2021-02-06 | swelling | Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm. |
| 59 | 2021-02-08 | peripheral swelling |
Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my ri...
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Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my right hand up into my right elbow and swelling of all my right fingers except my right thumb. It took several days for the symptoms to clear and required that I take one PTO day since I couldn't type or hold a mouse.
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| 59 | 2021-02-09 | oral herpes |
Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is ...
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Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unable to locate or read the details), via an unspecified route of administration on 19Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included psoriasis, high blood pressure, thyroid removal. The patient had no Known allergies. The patient other concomitant medications in two weeks included guselkumab (TREMFYA), levothyroxine sodium (SYNTHROID), aspirin (acetylsalicylic acid), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC). Prior vaccination, the patient had not had COVID, not tested post vaccination. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 19Dec2020 at 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweats on 20Jan2021 07:00. The patient did not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021. The outcome of the events charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweat was recovered in Jan2021. Information on the Lot/Batch number has been requested.
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| 59 | 2021-02-10 | lymph node swelling |
Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This...
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Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This is a spontaneous report from a contactable physician. A 59-year-old female patient received first dose of intramuscular (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021 at 14:45 at a single dose in left arm for Covid-19 immunisation at the age of 59-year-old. Lot number was EL0142. Medical history included Hashimoto's thyroiditis, Gastrooesophageal reflux disease (GERD), obesity, anxiety, Known allergies (Seasonal pollen, dust, dander). The patient was not pregnant. Historical vaccination included influenza vaccine on 21Dce2020 for immunization. Concomitant medications included aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), sertraline hydrochloride (Zoloft) and lorazepam. On 18Jan2021, the patient experienced painful cervical adenopathy, overlying erythema of skin, painful swallowing on side of vaccine with onset day 1 post vaccine, start of improvement on day 5, the patient was still with adenopathy on day 10. The patient was treated with ibuprofen and acetaminophen. The patient recovered from the events with lasting effects. Prior to vaccination the patient did not have Covid-19; since vaccination the patient was not tested for Covid-19.
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| 59 | 2021-02-10 | lymph node swelling |
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus...
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first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
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| 59 | 2021-02-10 | swelling face |
Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vacci...
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Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vaccine given thru work and did well after administration. Woke up next day with swelling in Lt. side of face and puffiness, tried applying ice but caused itchiness, no other sxs reported. Pt was advised to come in and be seen in clinic for evaluation. pt then was added to the schedule same day 2/11/2021 @ 1:45pm .
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| 59 | 2021-02-11 | axillary mass |
Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @...
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Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @ 9:30am) Dose 2 it got red, hot & a lump at the site of injection. Also, had lump under armpit, was told it was lymphadenopathy, had moderate pain in lower back & mild pain in other joints, also developed fever of 99.4 (my normal temp is 97.4) & chills. This was mostly on the 1st & 2nd day after the vaccine. the swelling under armpit & in arm are better but not completely gone yet & it is now day 4 after the injection (injection on 2/8/21) (was received on 2/8/21 @ 10:37am)
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| 59 | 2021-02-13 | lymph node swelling | Bilateral shoulder and hip joint pain. Also swollen glands in left shoulder and under arm. |
| 59 | 2021-02-14 | anaphylactic reaction |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
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| 59 | 2021-02-19 | swelling |
Redness which is hot to touch. Swelling in the same area of redness, firm/hard to touch. This is a c...
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Redness which is hot to touch. Swelling in the same area of redness, firm/hard to touch. This is a couple of inches below the injection site. There was no pain or any feeling whatsoever when given the injection.
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| 59 | 2021-02-23 | lymph node swelling, lymph node pain |
One week after 1st vaccine dose, hard lump from lymph node in Right axillary with general pain/swell...
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One week after 1st vaccine dose, hard lump from lymph node in Right axillary with general pain/swelling. About 4 days later lymph node started to soften but the swelling and pain remained. AT time of 2nd dose the swelling and pain were less, but not fully resolved, so dose give in left thigh. Four days after second dose, right axillary lymph node harden with increased pain/swelling. Lymph node soften over the course of a week, but the swelling and pain continues 2 weeks post dose (2/24/21). Treated with lymph-edema message/exercises, ice, and NSAID (Celebrex alternating with Acetaminophen) throughout and continuing.
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| 59 | 2021-02-24 | lymph node swelling |
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen...
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Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
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| 59 | 2021-02-24 | swelling, lymph node swelling, swelling face |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-27 | swelling face | Face turned red for about 2 hours, swollen face |
| 59 | 2021-02-28 | lymph node swelling, lymph node pain |
fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left c...
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fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient. A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Jan2021, The patient experienced fatigue, swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021. No treatment was given for the events. The clinical outcome of the events fatigue, swollen lymph nodes above the left clavicle that sore was not recovered.
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| 59 | 2021-02-28 | peripheral swelling |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-03-01 | swelling |
felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her neckl...
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felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-02 | lymph node swelling | Pain, swollen gland, flu, chills, tinnitus, fatigue |
| 59 | 2021-03-03 | peripheral swelling |
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ...
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her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
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| 59 | 2021-03-06 | lymph node swelling |
Headache, bodyache, chills lasted two days. Sore arm at shot, swollen lymph nodes under arm still th...
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Headache, bodyache, chills lasted two days. Sore arm at shot, swollen lymph nodes under arm still there.
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| 59 | 2021-03-07 | lymph node pain, lymph node swelling | Lymph nodes under same arm as injection was received are swollen and painful. |
| 59 | 2021-03-07 | oral herpes |
Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spont...
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Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK4176, intramuscular in the left arm, on 22Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Medical history included depression, SEM, Herpes Simplex 3 and BET. Concomitant medications included sertraline, clonazepam and propranolol. The patient also had thiomersal allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 25Jan2021, the patient experienced breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir. The outcome of event was recovered. Follow-up attempts are completed. The information on the batch/lot number has been obtained.
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| 59 | 2021-03-07 | peripheral swelling | Swelling under are, size of 1/2 baseball. Sore and painful. Resolving |
| 59 | 2021-03-09 | lymph node swelling | Left arm under armpit very sore including swollen lymph nodes. |
| 59 | 2021-03-09 | lymph node swelling | Lymph node swelling in left armpit |
| 59 | 2021-03-10 | axillary mass | Tired and a sore lump under my left armpit. |
| 59 | 2021-03-10 | swelling |
Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no...
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Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no tongue, lip or facial swelling, heart rate 90, respirations 16, lungs clear, 50 mg of Benadryl administered IM right deltoid at 11:33 AM with good effect, transported to the Medical Center via ambulance with advanced life support capability at 11:52 AM.
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| 59 | 2021-03-10 | white blood cell count increased |
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ...
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I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
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| 59 | 2021-03-11 | lymph node swelling |
Pfizer-BioNTech CoVID-19 Vaccine . Routine Office visit 3/11/21 with surgeon, previous melanoma as...
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Pfizer-BioNTech CoVID-19 Vaccine . Routine Office visit 3/11/21 with surgeon, previous melanoma as follow up. She advised my lymph nodes were swollen on the right side in my groin and under my arm. I also received my COVID vaccine in my right arm. Doctor will do another follow up in 30 days on 4/15/21.
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| 59 | 2021-03-11 | swelling face |
9 hours after injection, injection site started to swell significantly. after putting a cool towel a...
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9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack, started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
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| 59 | 2021-03-13 | swelling |
I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I ...
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I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I had to go to Urgent Care on 3/13 for IV fluids and still feeling sick all-over, headaches and muscle aches. Tested negative for Covid at Urgent Care. Initial report included headaches, body aches, injection site pain, swelling and bruising.,feeling sick all-over.
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| 59 | 2021-03-14 | lymph node swelling, peripheral swelling |
A lump appeared under the armpit (golf-ball sized). It is painful. Also appearing on upper arm on th...
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A lump appeared under the armpit (golf-ball sized). It is painful. Also appearing on upper arm on the same side (on inside of arm). No color.
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| 59 | 2021-03-14 | peripheral swelling |
03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever...
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03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied 03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness 03/15/21 - fatigue, dizziness, general body aches
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| 59 | 2021-03-15 | lymph node swelling, axillary mass |
Right underarm lymph nodes swollen and is a large mass. It is still swollen. I noticed it on Sunday,...
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Right underarm lymph nodes swollen and is a large mass. It is still swollen. I noticed it on Sunday, 3-14. I received my first Covid shot on Friday, 3-12, and my underarm is still swollen today, 3-16-21.
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| 59 | 2021-03-17 | anaphylactic reaction |
Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER ...
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Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER at 1:52, Released at 4:00 pm
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| 59 | 2021-03-17 | lymph node swelling |
Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint an...
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Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint and muscle pain and slightly swollen lymph nodes in my neck. Within a few hours, my body was completely covered in large hives from head to toe. I rested or slept most of the day and by the afternoon, the fever had subsided. By the next day headache, joint/muscle pain and swollen lymph nodes diminished. I still felt fatigue and the hives were awful. Began taking Benadryl with no relief. Called my primary care doctor to report; increased Benadryl dosage to 2 every 4 hours. There was some relief during the day, but the large doses of benadryl were making me anxious/nervous, racing heart, shakes. Decreased following another call to Doctor and began taking Antronex; decreaed side effects, but little affect on the hives during the evening/overnight hours. At times I would be completely covered in them, other times they were localized (bottoms of my feet, face, neck, eyes). Returned call to Doctor, again suggested Prednisone. (I typically have strong reactions to steriods and wanted to avoid if at all possible) Began first dose 3/18/2021. Experiencing some relief already.
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| 59 | 2021-03-18 | lymph node swelling |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-18 | lymph node swelling |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-18 | swelling face |
Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Withi...
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Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Within approximately 20 minutes the patient's swelling began to subside. Patient felt better and tongue was no longer tingling.
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| 59 | 2021-03-19 | lymph node swelling |
Swollen lymph node on collar bone, went to ER, they did ultrasound and chest x-ray on 01-11-21 sugge...
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Swollen lymph node on collar bone, went to ER, they did ultrasound and chest x-ray on 01-11-21 suggested follow up with doctor. 1/14/21 saw the doctor. He recommended a CT scan. The CT scan was completed on 1-29-21 and found multiple swollen lymph nodes throughout neck and chest. A biopsy was ordered. A needle biopsy was performed on the swollen lymph node on the collar bone on 2-2-21. No cancer was found. It was recommended to observe and wait and redo in 3 months if necessary. The swelling has been gradually lessening and is almost gone.
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| 59 | 2021-03-20 | peripheral swelling |
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg b...
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Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
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| 59 | 2021-03-21 | lymph node swelling |
8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and unc...
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8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and uncomfortable. On day 9, a red circular, itchy rash appeared. This expanded on day 10 (today). It is sore, itchy, red, has bumps, and my lymph node under my left armpit may be enlarged. Shoulder is slightly uncomfortable.
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| 59 | 2021-03-22 | lymph node swelling |
The lymph node on my collar bone on the same side, the left as both doses of my vaccine. After the s...
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The lymph node on my collar bone on the same side, the left as both doses of my vaccine. After the second dose the lymph node became more enlarged. It is the size of a marble that is still noticeable after eleven weeks. I am due to get an Ultrasound on the area to access the problem. Besides that, I just had mild headaches and tiredness for a short period. Second dose numberEL0142
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| 59 | 2021-03-22 | swelling face |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-03-23 | lymph node swelling | Swollen lymph node over left clavicle. |
| 59 | 2021-03-24 | lymph node swelling |
Went for mammogram the week following vaccination and had swollen lymph nodes in the armpit area. W...
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Went for mammogram the week following vaccination and had swollen lymph nodes in the armpit area. Was told that other women were experiencing the same thing.
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| 59 | 2021-03-24 | lymph node swelling |
On March 10th I felt pain in my right armpit for 36 hours and the lymph nodes were swollen in my arm...
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On March 10th I felt pain in my right armpit for 36 hours and the lymph nodes were swollen in my armpit. On the evening of March 10th I felt tired and unwell similar to having the flu. The next morning the flu like symptoms were gone
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| 59 | 2021-03-24 | lymph node swelling |
swollen lymph nodes under arm patient is taking Aleve for symptoms, recommended HCF eval if sx pers...
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swollen lymph nodes under arm patient is taking Aleve for symptoms, recommended HCF eval if sx persist
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| 59 | 2021-03-26 | anaphylactic reaction |
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif...
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Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
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| 59 | 2021-03-26 | lymph node swelling, swelling | Swelling at the neck, over left clavicle . Painful to touch. Lymphoid seem to be enlarged |
| 59 | 2021-03-26 | lymph node swelling |
3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light heade...
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3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light headed. Got chills. Hot & cold nauseated . It?s three days later I?m still very tired. Headaches , throats feels swollen , glands swollen. I feel like I got the flu! When is this going to end ?
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| 59 | 2021-03-27 | oral herpes |
High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Bo...
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High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Body aches Joints hurt Left eye became bloodshot and hurt Cold sores inside and outside of mout
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| 59 | 2021-03-28 | lymph node pain, lymph node swelling |
Painful, swollen lymph node under the jaw, left side Painful lymph node near armpit, left side Extre...
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Painful, swollen lymph node under the jaw, left side Painful lymph node near armpit, left side Extreme fatigue
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| 59 | 2021-03-28 | lymph node swelling |
First Vaccine received on Feb. 28, 2021 in right arm with mild fever and lethargy beginning around s...
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First Vaccine received on Feb. 28, 2021 in right arm with mild fever and lethargy beginning around six hours after injection and lasting for several days-manageable with Tylenol. Second Vaccine received on March 22, 2021: very small amount of soreness in left arm for first day. Begun to feel ill after about 15 hours. Fever of 100 with major body aches and chills for about 24 hours after this, not managed by Tylenol this time. Forty-eight hours after the injection the soreness at the injection site was minimal but there was major swelling and pain in the lymph nodes underneath the left arm as well as general fluid retention all over ( five pound weight gain overnight). This swelling and pain was also present in the left chest area and continued for about four days with extreme discomfort. At this point, one week after the injection, the pain and swelling in the left armpit is reduced to mild discomfort and fluid retention has also reduced.
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| 59 | 2021-03-28 | swelling | Local swelling and soreness at injection site Difficulty sleeping following injection for one night |
| 59 | 2021-03-29 | c-reactive protein increased |
Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine adminis...
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Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine administration, began to experience myalgias, arthralgias (especially knees, shoulders), fatigue, conjunctival injection, papular rash to L arm>trunk and other extremities. Day 17 after vaccine, seen in ED for above symptoms with neg COVID, HIV, Hepatitis testing. Day 21 after vaccine, seen again in office with persistent arthralgias, noted to have ESR and CRP elevated, returning to normal by 34 days after vaccine. Seen by me on day 47 after vaccination with persistent fatigue, mental fog, and arthralgias in knees.
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| 59 | 2021-03-29 | oral herpes |
A cold sore developed just above my lip, on the right side. I typically get one maybe once every two...
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A cold sore developed just above my lip, on the right side. I typically get one maybe once every two years. This seems to have come out of nowhere. Not sure if the vaccine activated the virus or this is cirumstantial.
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| 59 | 2021-03-30 | lymph node swelling |
Delayed reactions: 6 days after shot, swollen & painful lymph nodes under left arm Delayed reactions...
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Delayed reactions: 6 days after shot, swollen & painful lymph nodes under left arm Delayed reactions: 9 days after shot, hot, red, painful swelling at injection site on left arm, approximately 2" diameter Patient using ice, Tylenol, and Benadryl to manage symptoms
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| 59 | 2021-03-30 | swelling face |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: swelling in mouth - tongue/throat. white spots on lip/mouth. vaccine given 11:07, sx started ~11:17, benadryl given 11:20, EMS arrived 11:34. Patient was fine and stable, left with husband a few minutes later. counseled on what to do if symptoms reemerge.
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| 59 | 2021-03-31 | swelling face |
Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience...
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Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience Fever; Drooping & Swelling on right side of face on 03/30/21. Swelling is decreasing but there is still some drooping. The patient is Epileptic and is also taking Dilantin and Phenobarbital to control the seizures.
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| 59 | 2021-04-01 | swelling face |
At vaccine center, patient reported shortness of breath and facial swelling. Epi pen given and patie...
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At vaccine center, patient reported shortness of breath and facial swelling. Epi pen given and patient went to the ED.
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| 59 | 2021-04-02 | peripheral swelling |
Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after...
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Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after vaccination. Pain and swelling continue without abating after 2 weeks of rest, compression, ice, elevation. Stye in left eye - possibly due to inflammation in eyes. Treating with moist heat.
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| 59 | 2021-04-03 | lymph node swelling | Swollen lymph node in armpit; injection site arm |
| 59 | 2021-04-03 | swelling face |
Patient reports around midnight the day of 1st covid vaccine that she felt a sensation in her face, ...
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Patient reports around midnight the day of 1st covid vaccine that she felt a sensation in her face, and began to get swelling and rash on right side of face. She states that it progressively got worse. Upon waking patient took a Benadryl tablet, and came to the pharmacy to get further direction. Initially on 3/17/21 she was directed to call primary care doctor (who is located about an hour from home) and if symptoms worsened or she started having issues around mouth or trouble breathing seek an urgent care or emergency room. Patient reported on 4/3/2021 that she had contacted doctor and they wanted her to continue the benadryl until resolved but did not believe that the reaction warranted a steroid and instructed that she could get second dose of vaccine.
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| 59 | 2021-04-04 | peripheral swelling |
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something...
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25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
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| 59 | 2021-04-05 | anaphylactic reaction, swelling face, swelling | anaphylaxis response Swelling of neck/face/eyes, difficulty in breathing |
| 59 | 2021-04-17 | white blood cell count increased |
she was in distress with her throat starting to swell, her tongue started to swell and she was cover...
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she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date. The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021. Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.
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| 59 | 2021-04-18 | guillain-barre syndrome |
Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th...
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Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th 36 hours after shot went down her back to but and legs. Friday April 16,2021 she could not walk. Hospital on the 16th by the 17th her arms and hands were affected. Still in the hospital to current date receiving IVIG to see if that will work for her.
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| 59 | 2021-04-25 | guillain-barre syndrome |
Presented to primary care physician, with c/oe back pain which started on 4/10/21. Then presented to...
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Presented to primary care physician, with c/oe back pain which started on 4/10/21. Then presented to ER for increased pain for inferior neck pain. Treated with Medrol dosepak with tramadol, Went to Health Clinic for xrays which were reported as negative. Right hand numbness and third thru fifth fingers on left hand are numb. Generalized altered sensation throughout her entire body. Admitted to hospital on 4/16/21 and evaluated by hospitialist, neurology (Guillain-Bare- new diagnosis) nephrology (SIADH), cardiology (chest pain- negative workup) neurosurgery (Thoracic lesion at T6-T7). Discharged to rehab on 4/24/21 for approximately 10 days- pain management/mobility.
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| 59 | 2021-04-25 | white blood cell count increased |
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department reporting three weeks...
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Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department reporting three weeks of progressively worse dyspnea on exertion with chest tightness and tachycardia. Initial vital signs within normal ranges. Patient admitted to hospital for observation and testing but left against medical advice before completion.
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| 59 | 2021-04-26 | peripheral swelling |
Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low ...
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Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low grade fever. I took Tylenol and the chills and fever went away Friday night, The pain in my arm went away by Sunday, 4/25. My blood pressure went down after drinking more water. I can still feel the lump but its not as painful.
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| 59 | 2021-04-27 | swelling face, peripheral swelling |
Right index, middle and ring finger swelling, abdominal distinction, facial swelling, Left fingers s...
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Right index, middle and ring finger swelling, abdominal distinction, facial swelling, Left fingers swelling. Had to take pain relievers to use hands for activities of daily living.
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| 59 | 2021-04-27 | swelling |
Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 wi...
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Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 with no adverse reactions. She received her second one on 4/5/21 with lot #EP7533. She reports she started "feeling bad" 4/6/21-4/11/21. She noticed left sided neck swelling on 4/11/21. She went to urgent care and was seen by an NP and was told to go to for a CT scan the next day since it was on a Sunday. Patient reports she went home and had further left sided neck swelling and difficulty breathing. She "couldn't catch her breath". EMS was called and she was transported per her request to Hospital. She had a 9 day hospital stay and was told she was having a severe reaction to the vaccine and that she had pneumonia with fluid in her lungs and fluid around her heart. She was treated with 2 antibiotics, IV fluids, and a diuretic. Patient had a follow up with her primary care on Monday 4/26/21 with NP and was told her heart and lungs sounded clear. She has a follow up appt scheduled with her lung doctor Dr on 5/24/21. Patient did not say why she has seen a lung doctor before but that she had been seeing this doctor prior to this adverse reaction. She was told in the hospital that it was not normal to be having this much swelling. Patient states she still feels weak and is still somewhat short of breath.
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| 59 | 2021-04-30 | lymph node pain |
acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cy...
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acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cysts except both sides were hurting; had trouble catching breath with the pain; arm pain; brain fog/head started feeling foggy and weird; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 16:00 (Lot Number: EN5318, Expiry date: 31May2021) on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included flu shots. The patient stated her physician told her she had an acute lymphatic response. She added there was something about 3 am (18Mar2021) because she woke up at 3 am and had severe pain in some of her lymph nodes. In particular, the ones around her ovaries. She added that she was old and her ovaries had not worked in a long time. She had severe pain like cysts except both sides were hurting. She also had trouble catching breath with the pain. This lasted 45 minutes and subsided. The next morning 18Mar2021, when she got up some of her lymph nodes were very panful and there was one even that was a node visible down her throat almost at the base of her neck in the center. She could see it sticking out, it was crazy. It went down in about three days. The pain and the weirdness in all of her other lymph's was about 3 or 4 days. It was an odd response and people told her it was just her body acting like a young person and was going to work. This was the first issue she had with the vaccines. The patient also experienced brain fog after first vaccine on 17Mar2021: within 2 or 3 minutes of having them her head started feeling foggy and weird. It was after the first vaccine, she thought it was psychological but it did not go away and it was not psychological. It was like a weird foggy and like taking sinus medication, no additional details. When it happened with the first vaccine, it did not concern her as much as the first one. It went away after the first vaccine probably late that evening (17Mar2021), around 10:30 pm right when her arm started to hurt. She did not have arm pain that was severe. She added maybe it lasted a day. The next day it hurt but it was not anything bad, it just hurt to touch it and to lift it hurt for a day. Maybe this was for 36-40 hours before the pain went out. The outcome of event "trouble catching breath with the pain" was resolved on 18Mar2021 03:45, outcome of event "brain fog/head started feeling foggy and weird" was resolved on 17Mar2021, outcome of other events were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-30 | peripheral swelling |
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he...
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they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
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| 59 | 2021-05-05 | swelling face |
Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine ra...
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Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine rash on cheeks/chin and face swelling, roof of mouth felt slightly swollen and lips tingly feeling slightly swollen, pills felt stuck in back of throat. went back in facility they told me to take Benadryl and go to doctor or ER if it gets worse, took Benadryl and Zyrtec and started past allergic reactions protocol, up to 4 Zyrtec and 4 Allegra in a day and Benadryl as needed. QNasl. Saw nurse practitioner who added Pepcid 2times a day. Did this for 3 weeks pills still feel stuck at back of throat on and off in a day.
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| 59 | 2021-05-10 | swelling |
Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they wer...
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Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they were red and hard; Arm was sore; puffy/swollen; She had a breakout on her face, a couple of lesions, and her mouth broke out.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergic to Penicillin, crustaceans, shellfish, and mushrooms. Those were what she usually had a breakout for. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and second degree burns. Her reaction to amoxicillin was probably 15 years before. The patient had a reaction to her first Covid-19 shot. She took the first shot last Tuesday. She had a breakout on her face, a couple of lesions, and her mouth broke out. It looked like a reaction. She took a couple of diphenhydramine hydrochloride (BENADRYL), and it was going away. Her second shot was scheduled for next Tuesday 11May2021. She needed to know if there was anything in the shot that would cause this. She was leery of taking it. She was okay with it, and the diphenhydramine hydrochloride was fine. She did contact her doctor. That was it, she had nothing else just the breakout. She thought it was maybe Thursday 22Apr2021 or Friday 23Apr2021 that she noticed the breakout on her face. She started trying to take some diphenhydramine hydrochloride. It was rapid when it happened, not slow. She saw these as almost like a reaction. She had welting on the skin similar to a reaction to dust mites. There was this thing she thought was just a zit that broke out on the top of her eyebrow. There were hard little bumps. One had gone away, and the other was still there. It was almost like when she had a breakout of zits was kind of what she would say. It was dissipating. She started taking rounds of diphenhydramine hydrochloride to stop the reaction, and it was working. She was concerned about the second shot. She didn't know if it was an allergic reaction to amoxicillin or any other type of medicine if it was in there. That was what she was concerned about. Before she got the second shot she needed an idea of what might have happened. The lesions came a day or so after the breakout on her face. She would say Sunday 25Apr2021 was when she saw the lesions above her eyebrows. It was right at the beginning of her eyebrow. It was really hard at first. It was not itching, just like zits. Similarly, they were red and hard. Once again she started the diphenhydramine hydrochloride and saw a little bit of difference, but had to keep putting on topical Aquaphor and cocoa butter. She had to keep putting it on there, it was just swollen. The lesions were puffy and red. There was just one left, it was going down. Her mouth was the number one thing. She thought it was from wearing a mask. She had never had a breakout with a mask before. She took the shot on Tuesday, and her arm was sore just for 24 hours. She noticed her mouth broke out Thursday or Friday for sure when she woke up. At first she just kind of forgot about the shot and didn't put two and two together. She took diphenhydramine hydrochloride. It was the same type of reaction she would have if it was amoxicillin. She really needed to know if she should anticipate something with the second shot. Outcome of event a breakout on her face, a couple of lesions, and her mouth broke out was resolving, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 59 | 2021-05-18 | guillain-barre syndrome |
AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a conta...
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AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a contactable Physician. A 59-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) vaccination at the age of 59 years old as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bunion surgery between CCPD and vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had acute onset peripheral and central demyelination as confirmed on MRI (magnetic resonance imaging) brain and spine with and without contrast. AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) confirmed with two NCC/EMG (NCC Electromyography). Patient presented with lower extremity weakness, upper and lower motor neuron signs, somnolence, upper extremity dysmetria, and right lower facial droop. This occurred 22 days after first vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for the adverse event included PLEX (Plasmapheresis) x 5 treatments, and methylprednisone x 5 days followed by prednisone taper. The outcome was recovering. Information of the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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